external_catalog

External Product Catalog & Surgical Technique Manual

CorporateOverview

ExternalSystemOverview

Product Catalog

Implants

HealingAbutmentsandCoverScrews

SurgicalKitandComponents

AncillarySurgicalInstruments

CollateralLiteratureandSupportMaterial

W&HSurgicalMotorsandAccessories

ProstheticOverview

ImpressionComponentOverview

3inOne™ andCeramicAbutments

EstheticAbutments(AngledandStraight)

AngledandStraightAbutments

ProfileandNon-hexedAbutments

CustomCastable(UCLA)Abutments

PEEKTemporaryandTitaniumTemporaryAbutments

Ball-topScrewsandIndirectTransferCopings

DirectPick-upCopings

ImplantAnalogsandScrews

AbutmentsforScrewandComponents

BallAbutmentsandComponents

ProstheticInstrumentation

PatientEducation

Surgical Manual

Introduction

ImplantSpecifications

SurgicalProtocols

ExternalImplantSpacing

RadiographicTemplate

SurgicalKit

SurgicalDrillsandInstrumentSequenceReview

OsteotomyInitializationandParallelPins

DepthandWidthIncreasingDrills

CrestalBoneDrillsandBoneTaps

ImplantPackaging/ImplantPick-up

ImplantPlacement/AbutmentRemoval

InsertionTools/CoverScrews/HealingAbutments

BoneProfilers/BurtestingGauge

SurgicalKitCleaning

DrillInstructionsforUse/Post-operativeInstructions/References

OrderingandWarrantyInformation/IconLegend

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2-3

4

5

6-7

8-9

10-11

12-13

14-15

16-17

18

19

20

21

22-23

24

25

26

27

28-29

30-31

32-33

34

35

36

37

38-39

40

41

42-43

44-45

46-47

48-49

50-51

52-53

54-55

56

57

58-59

60-61

TABLEOFCONTENTS

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No single implant design is perfect for every indication soBioHorizons lets clinicians choose the implant best suited to theirpreferencesandtheneedsoftheirpatients.Noothercompanyoffersmore choices of specialty implants, body shape, connection type,surfacetreatmentandrestorativepathsthanBioHorizons.

AllBioHorizonsimplantsandcomponentsareprecisionmanufacturedto the tightest mechanical tolerances in the industry. This yieldsproductswithaform,fitandfunctionyouwillappreciatethefirsttimeyoupickthemup.

Innovativeoptions...notcompromises

Patientsatisfaction:DeliveredHappy patients are the driving force of successful dental practices,and clinicians know they don’t want implants; they want teeth. Buttraditionally,companieshaveonlyguaranteedtheirimplants!

Beginningin2008,1-unitto3-unitrestorationsmadeonourimplantsatselectlaboratoriesusinganapprovedtreatmentplanareguaranteed for life. If the prosthesis fails, BioHorizons covers the cost of therework…noredtape,nosmallprint.

Thisisjustoneexampleoftheworld-class customer service youcanexpectfromBioHorizons.

BioHorizonsrecentlyintroducedLaser-Lok® microchannelstothecollarsofitsinternally-connectedimplants.Laser-Lokisapatentedlaser-machinedsurfacetreatmentwithover15yearsofin vitro,animalandhumanstudies.Laser-Lok has been shown through SEM analysis and human histology toinhibit epithelial downgrowth, achieve connective tissue attachment andretaincrestalbone.1

BioHorizons External has a long history of clinical success,includingexcellentmaintenanceofcrestalbone.2WearecurrentlyinvestigatinghowtheadditionofLaser-LoktoExternalmightfurtherenhancetheperi-implantboneandsofttissuecomplex,leadingtooptimalestheticoutcomes.Ifwecanfindawaytomakeagreatimplantevenbetter,restassuredwewill.

Committedtocontinualimprovement

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external

Why pay for a prepable, gold-hued esthetic abutment if you don’t have to?

EveryExternalimplantispackagedwitha3inOne™Abutment,CoverScrewandAbutmentScrew.Most implantcompaniesmakeyoupayextraforaprepableestheticabutment.Usingthe3inOneAbutmentkeepsinventoryandoverheadcoststoaminimumandreducesthechanceofnothavingthecorrectcomponentstocompletethecase.

Gold-huedTiNcoatingforsofttissueesthetics

PatentedGuidePinsavestimeandeliminatescross

threading

Low-profileAbutmentScrewusesindustry

standard.050”(1.25mm)hex

Spiralock®technology

virtuallyeliminates

screwloosening

Prostheticplatform0.2mmwiderthanimplantbody

Stable1mmhighexternalhex

Statedimplantlength

Implantbodydiameter

0.5mmmachined

collar

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Externalimplantsfeaturethetime-proven,biomechanicalsquarethreadwhichhasbeendemonstratedtoprovideincreased bone-to-implant contact and yield higher reverse-torque values.

Biomechanical Thread Form | Backed by Science

DegidiandPiattelli.Immediate Functional and Non-Functional Loading of Dental Implants: A 2- to 60-Month Follow-Up Study of 646 Titanium Implants. JPeriodontology2003;74:225-241.

NImplants NFailures %ImplantSurvival %ProsthesesSurvivalBioHorizonsImplants

126 0 100% 100%ImmediateFunctionalLoading

ImmediateNon-FunctionalLoading 116 0 100% 100%

V-thread Modified-square

15.58±6.07

65.46±9.64

23.17±9.68

74.37±8.63

ReverseTorqueValue(Ncm)

%Bone-to-ImplantContact

SteigengaJ,Al-ShammariK,MischC,NocitiFandWangH-L.Effects of Implant Thread Geometry on Percentage of Osseointegration and Resistance to Reverse Torque in the Tibia of Rabbits. JPeriodontology2004;75:1233-1241

MultiplestudieshavedemonstratedtheBioHorizonssquarethreadtobeextremelyreliableinimmediateloadingprotocols.Onestudy,summarizedbelow,followed242BioHorizonsimplantsthroughimmediatefunctionalandnon-functionalloading.

Crestal bone maintenance leads to success

A prospective, multicenter trial showed a 5-year cumulative success rate of 99.5% for 495 Externalimplantsin151patients.Therewerenosignificantdifferencesintheresultsbycenter,implanttype,bonedensity,areaof themouthorprosthesis type.Crestalbone loss fromprosthesisdelivery toone-yearfollow-upwasextremelylow(0.06mm),andactuallyturnedintobonegainatlaterfollow-upintervals.2

Radiographs of External implants in function for more than 6 years. Note that the crestal bone levels are maintained above the level of the first thread. Courtesy of Dr. Carl E. Misch.

Increased surface area for immediate loading success

Boneisstrongestincompressiveloading;weakestinshear.External’ssquare-threaddesignimparts10timeslessdestructivestressesattheimplant/boneinterfacethanconventionalv-threaddesigns,whilemaximizingcompressiveloadtransferandprovidingexcellentprimarystability.Theseattributeshavebecomeincreasinglyimportantwiththeemergenceofearlyandimmediateloadprotocols.3,4,5

Thesquare-threaddesignprovidesupto154%greatersurfaceareathanconventionalv-threaddesigns.Acomparativestudyofthreaddesigns(square-thread,v-threadandbuttressthread)concludedthatthesquare-threaddesignexhibitedsignificantlyhigherreversetorquevaluesandbone-to-implantcontactthantheotherthreaddesigns.6

Conventionalv-thread

BioHorizonssquare-thread

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products shown not to scale

Eachimplantispackagedwiththe3inOneAbutment,CoverScrewandAbutmentScrew.ChoiceofRBTorHAsurfacetreatment(exceptØ3.5mm:RBTonly).Orderbylengthanddiameter.TitaniumAlloy[Ti-6Al-4V].

Resorbable Blast Texturing (RBT)

Roughened TiO� surface

Hydroxylapatite Coating (HA)High-density

crystalline coating

�509D�

�5�05D�

�5��D�

�5�5D�

Ø�.5mm x 9mm

Ø�.5mm x �0.5mm

Ø�.5mm x ��mm

Ø�.5mm x �5mm

6009D�

60�05D�

60��D�

60�5D�

6009D�

60�05D�

60��D�

60�5D�

Ø6.0mm x 9mm

Ø6.0mm x �0.5mm

Ø6.0mm x ��mm

Ø6.0mm x �5mm

5009D�

50�05D�

50��D�

50�5D�

5009D�

50�05D�

50��D�

50�5D�

Ø5.0mm x 9mm

Ø5.0mm x �0.5mm

Ø5.0mm x ��mm

Ø5.0mm x �5mm

�009D�

�0�05D�

�0��D�

�0�5D�

�009D�

�0�05D�

�0��D�

�0�5D�

Ø�.0mm x 9mm

Ø�.0mm x �0.5mm

Ø�.0mm x ��mm

Ø�.0mm x �5mm

Diameter x Length

EXTERNALIMPLANTS

NA

NA

NA

NA

Implants

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�0�-60�

�0�-60�

�0�-606

�0�-50�

�0�-50�

�0�-506

Includedwitheachimplantsystem.Protectstheimplant’sprostheticplatformduringsubmergedsurgicalhealing.Color-codedbyimplantdiameter.Hand-tightenwiththe.050”(1.25mm)HexDriver.TitaniumAlloy[Ti-6Al-4V].

Usedfortissuehealingatsecond-stageuncoveryorasatransmucosalelementforsingle-stageprocedures.Color-codedbyimplantdiameter.Hand-tightenwiththe.050”(1.25mm)HexDriver.TitaniumAlloy[Ti-6Al-4V].

Ø�.5mm Cover Screw

Ø�.0mm Cover Screw

Ø5.0mm Cover Screw

Ø6.0mm Cover Screw

�0�-900

�0�-900

�05-900

�06-900

�0�-�0�

�0�-�0�

�0�-�06

��-60�

��-60�

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Ø6.0mm x �mm

Ø6.0mm x �.5mm

Ø6.0mm x 6mm

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��-506

Ø5.0mm x �mm

Ø5.0mm x �.5mm

Ø5.0mm x 6mm

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Ø�.0mm x �mm

Ø�.0mm x �.5mm

Ø�.0mm x 6mm

Ø�.5mm x �mm

Ø�.5mm x �.5mm

Ø�.5mm x 6mm

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HEALINGABUTMENTSANDCOVERSCREWS

HealingAbutments

CoverScrews

Straight Emergence Flared EmergenceImplant Diameter x Height

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�60-500

External Surgical KitIncludesallinstrumentsshownonpages6-7.

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�.0mm Starter Drill

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Drill Extender

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��-�00

Straight Parallel Pins (4perkit)

�0° Angled Parallel Pins (2perkit)

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�.5 x 9mm Depth Drill

�.5 x �0.5mm Depth Drill

�.5 x ��mm Depth Drill

�.5 x �5mm Depth Drill

�.5mm Depth Drill (withoutDepthStop)

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��-��7

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�.0mm Width Increasing Drill

�.�mm Width Increasing Drill


�.�mm Width Increasing Drill


5.�mm Width Increasing Drill

�60-�00

Surgical Tray & Lid (without instruments)

SURGICALKITANDCOMPONENTS

ExternalSurgicalKit

IndividualSurgicalKitComponents

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�.5mm Crestal Bone Drill

�.0mm Crestal Bone Drill

5.0mm Crestal Bone Drill

6.0mm Crestal Bone Drill

�.5mm D� Bone Tap

�.0mm D� Bone Tap

5.0mm D� Bone Tap

6.0mm D� Bone Tap

��-�00

��-�00

��5-�00

��6-�00

��-000

��-000

��5-000

��6-000

�.5mm Handpiece Adapter

�.0/5.0/6.0mm Handpiece Adapter

��-�00

��5-�00

�.5mm Ratchet Adapter

�.0/5.0/6.0mm Ratchet Adapter

�0�-�00

��5-�00

�.5mm Implant-level Insertion Tool

�.0mm Implant-level Insertion Tool

5.0/6.0mm Implant-level Insertion Tool

�5�-000

�5�-000

�55-000

��5-�5�

Hand Wrench

.050” (�.�5mm) Hex Driver

�00-�00

Ratchet & Hand Wrench Extender

�00-�05

Implant Spacer / Depth Probe

��-�00

Ratchet

��0-000

SURGICALKITCOMPONENTS

IndividualSurgicalKitComponents

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�50-000 Surgical Driver

Used to place implants in the osteotomy; particularly useful in the anterior.TheSurgicalDriverholds theRatchetAdapters that interfacewith the3inOneAbutment,aswellasBoneTapsandInsertionTools.Alsousedwiththe.050”(1.25mm)HexDrivers(ref.300-350and300-351,soldseparately).

ExtendedShankDrills(not included in Surgical Kit)

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��-��507

��-��509

��-��5�05

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��-��5�5

��-��5

�.0mm Starter Drill, Extended Shank

�.5 x 7mm Depth Drill, Extended Shank

�.5 x 9mm Depth Drill, Extended Shank

�.5 x �0.5mm Depth Drill, Extended Shank

�.5 x ��mm Depth Drill, Extended Shank

�.5 x �5mm Depth Drill, Extended Shank

�.5mm Depth Drill, Extended Shank

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��-��7

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��-�5�

�.0mm Width Increasing Drill, Extended Shank

�.�mm Width Increasing Drill, Extended Shank


�.�mm Width Increasing Drill, Extended Shank


5.�mm Width Increasing Drill, Extended Shank

ExtendedShankDrillsare8mmlongerthanourstandarddrills.Theyprovide an intermediary increase in length between the standarddrillsusedalone,orwiththeDrillExtender(ref.122-100),whichadds16mmoflength.Thedepthmarksandcuttinggeometryareidenticaltoourstandarddrills.

SurgicalDriver(not included in Surgical Kit)

ANCILLARYSURGICALINSTRUMENTS

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AncillaryInstruments(not included in Surgical Kit)

��-��0 Ø�.0mm Lindemann Bone Cutter

Side-cuttingdrillusedtocorrecteccentricosteotomypreparations.

ForinstallationandremovalofCoverScrews,HealingAbutmentsandAbutmentScrews.Usewithlatch-typecontra-anglehandpieces:WS-75E/KMorsimilar.134-450is5mmlongerthanthe134-350.

��-�50

��-�50

.050” (�.�5mm) Handpiece Hex Driver

.050” (�.�5mm) Handpiece Hex Driver, Long

�.5/�.0mm Tissue Punch

5.0mm Tissue Punch

6.0mm Tissue Punch

External Bone Profiler, �.5mm

External Bone Profiler, �.0mm

External Bone Profiler, 5.0mm

External Bone Profiler, 6.0mm

Usedatimplantuncoverytocontourcrestalbonetoaccommodateabutmentswhentheimplant is subcrestal. For use in latch-type reduction handpieces. The Profiler’s internalgeometrymatchesthegeometryofthesurgicalCoverScrewwhichalignstheProfilerforpreciseremovaloftissuesurroundingtheplatform.

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BioHorizonsTissuePunchesareusedinalatch-typehandpiecetoremovethesofttissuefromthecrestoftheridgepriortoosteotomypreparationinaflaplesssurgicalprocedure.

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ANCILLARYSURGICALINSTRUMENTS

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ExternalSurgical

L0�50 External Radiographic Implant Template (overlay) Designedtoaidtheclinicianinthepreoperativedeterminationofoptionsforimplantlengthanddiameter.Theclearoverlaytemplateshowsallsizesof BioHorizons External implants in 100% and 125% scale. Packagedwitheachnewsurgicalkit,butalsoavailableuponrequest.

L0��0

External Depth Mark and Drill Sequence Chart11’’x17’’(28cmx43cm)wallchartdetailstheDrillDepthMarksandrecommended sequence of use for the instruments found in theExternalSurgicalKit(ref.160-500).Packagedwitheachnewsurgicalkit,butalsoavailableonrequest.

External Surgical Kit Wall Chart11’’x17’’(28cmx43cm)wallchartdetailsthelocationofinstrumentsin the External Surgical Kit (ref. 160-500), as well as the referencenumberstoassistre-ordering.Packagedwitheachnewsurgicalkit,butalsoavailableuponrequest.

External - 7mm Length Implants Guides the clinician and laboratory through the nuances of placing andrestoring BioHorizons External 7mm length implants. Includes orderinginformationforimplants,2.0x7mmDepthDrillsandRadiographicTemplateswith7mmlengthimplants.NOTE: 7mm length implants are not available in all countries; please call for availability in your market.

L0�5�BioHorizons External - 7mm Length Implants

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COLLATERALLITERATUREANDSUPPORTMATERIAL

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Regeneration Specialty CatalogOrderinginformationforAlloDerm®,Grafton DBM®,Mineross®,Mem-Lok®,AutoTac®TitaniumtackingsystemandBoneFixationScrewKit.Awidearrayofboneandsoft-tissuegraftinginstrumentsarealsoshown.

ML0�0�

ExternalProsthetic

RegenerationProductsandSpecialtyInstruments

BioHorizons External Impression Technique Guide

External Impression Technique GuideGuidestheclinicianandlaboratorythroughimpressionmakingtechniquesandprocedureswithBioHorizonsExternalimpressioncomponents.

ML0�07

Animated Restorative Technique GuideGuides the clinician and laboratory through impression making techniques andprosthetic/lab procedures with the BioHorizons 3inOne Abutment and Ball-topScrew,aswellasotherrestorativeprotocols.

MLV��9

Animated Restorative Technique Guide

COLLATERALLITERATUREANDSUPPORTMATERIAL

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WH-ITC9�5

WH-9�5MC

WD-79M

WH-915One-pieceDisposableIrrigationSet(6pack)

ImplantMed915MotorCable-1.8meter

W&HEndoContra-angle2:1HandpieceWD-79NotincludedinStarterKit.2:1speed-reducingratio.UsedwithImplantMed915formechanicalrootcanalpreparation.

Re-order items:

WH-9�5 W&H ImplantMed 9�5 Starter Kit

WH �00 W&H ElcoMed SA-�00 Professional Kit

Re-order items:

Maximum motor speed is 40,000 rpm. The motor comes with the WS-75 handpiece, bur testing gauge, (3)disposable irrigation assemblies, and service oil (shipped separately). The console has factory-programmedsettingsforendodonticfunctionswhenusedwiththeW&HEndoContra-angle2:1Handpiece.

Maximummotorspeedis50,000rpm.TheSA-200permitsthestorageoftorquecharacteristicsofatreatmentstage,whichcanthenbesavedonaDOCcardforarchivingpurposes.ThekitincludestheWS-75handpiece,(10)disposablespraytubes,burtestinggauge,irrigationspikeandserviceoil(shippedseparately).

WH-�00PTWC

WH-�00RPT (� PK)

WH-�00INI

WH-�00DOC

WH-�00MC

PumpTube(190mm)withConnectors

ReplacementPumpTubes(190mm)(3pack)

INICards(3pack)

DOCCards(3pack)

ElcoMed200MotorCable-1.8meter

WH-ST (�0 PK)

WH-CLP (�0 PK)

WH-�00PTWC

WH-�00RPT (5 PK)

WH-�00MC

WH-��0MC

WH-��0CLP (5 PK)

WH-��0PTWC

WH-��0RPT

WH-��0ISAWRC

WH-��0RC

WH-ISA

WH-ITWOS

WH-MD�00

WH-OSC

WH-SP

GreenSingle-UseSprayTubes(10pack)

SetofSprayTubeClamps(10pack)

PumpTubewithConnectors(65mm)


ElcoMed100MotorCable-1.8meter

ImplantMed110MotorCable-1.8meter

SetofSprayTubeClamps(5pack)

PumpTube(85mm)withConnectors


IrrigationSpikeAssemblywithRollerClamp

FlowRegulatingRollerClamp

IrrigationSpikeAssembly(autoclavable)

IrrigationTubingw/oSpike(autoclavable)

MD-400ServiceOil-F1

OilSprayCap

SterilizationPlugforMotorCable

AllW&HMotors

ElcoMed100&200

ElcoMed100

ElcoMed100

ElcoMed100

ImplantMed110

ImplantMed110&915

ImplantMed110&915

ImplantMed110&915

ImplantMed110&915

ImplantMed110&915

AllW&HMotors

AllW&HMotors

AllW&HMotors

AllW&HMotors

AllW&HMotors

Ref. Code Description Motor Compatibility

W&HImplantMed915

W&HElcoMedSA-200

UniversalandLegacyRe-orderItems

W&HMOTORSANDACCESSORIES

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W&H �:�.7 Contra-angle Speed Increasing Handpiece 1:2.7speed-increasingratio-135,000rpmmaximum.Contra-angleHandpiecesuitableforhighspeedpreparationandtissueaugmentationprocedures.External irrigationport.Usesfriction-gripburs(Ø1.6mm).

W&H �0:� Contra-angle Handpiece WS-75 E/KMContra-angleHandpiecewithspeedreductionratioof20:1(2,500rpmmaximum).Equippedforbothinternalcooling&externalcooling.Push-buttonburrelease.Useslatch-typesurgicaldrillsandburs.

W&H �:� Straight Surgical Handpiece 1:1ratio-50,000rpmmaximum.Suitableforboneharvesting,thirdmolarextractionsandosteoplasty.Easilydismantledforcleaning.Uses45mmfriction-gripsurgicalburs(Ø2.35mm).

S-��

WS-75

WS-9�

W&H �:� Contra-angle Surgical Handpiece1:2speedincreasingratio-80,000rpmmaximum.Suitableforsurgicalproceduressuchasbonesmoothing, thirdmolarextractionsandosteotomysitedrilling.Highprecisionbearingsensurethattheunitrunsvibrationfree.Usesfriction-gripsurgicalbursatleast65mmlong(Ø2.35mm).

S-��

Usedtoverifytheconditionoflatch-typeburs.Bursinproperconditionwillfitintolargerdiameterhole,butwillnotfitintothesmallerhole(markedred).Bursthatfaileitherofthesecriteriaareunfitforuse,andmaycausedamagetothehandpieceifused.

WH-BTG Bur Testing Gauge

IMPORTANT NOTE: W&H motors and handpieces are distinguished by their precision craftsmanship and reliability and are

covered by a 1-year manufacturer’s warranty. Instructions for required cleaning and maintenance are outlined in each product’s

user manual, and adherence to these procedures is essential for proper function and longevity of the products. BioHorizons

assumes no liability for the failure of, or damage to, motors and handpieces that are not properly maintained or used contrary

to the instructions for use. Please contact your Product Support Specialist or Customer Care if you need additional information.

W&HElcoMedSurgicalHandpieces

BurTestingGauge

W&HMOTORSANDACCESSORIES

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Lab Modified Cement-retained

Custom Cast (UCLA) Screw-retained

Provisional Restorations

May also be modified chair-side.

Gold-base with burn-out plastic sleeve. Non-hex-engaging abutments are only for multiple-unit prostheses.

AbutmentsforCement-retentionPages ��-��

CustomCastableAbutmentsPages ��-��

PEEKAbutmentsPage ��

Cement-orscrew-retained

TitaniumTemporaryAbutmentsPage ��

Screw-retained

IMPLANT-LEVELFIXEDPROSTHETICOVERVIEW

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Implant-level Cast Bar or Hybrid (Fixed-detachable)

Abutment for Screw-level Cast Bar or Hybrid (Fixed-detachable)

BallAbutmentsPage �0

Abutment-retained Overdenture, Tissue-supported

AbutmentsforScrewPage ��

REMOVABLEANDHYBRIDPROSTHETICOVERVIEW

CustomCastableAbutmentsPages ��-��

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Ball-top Screw Closed-tray Transfer

Implant-level Open-tray Pick-up

Impression coping remains in mouth when impression tray is removed. Coping is transferred from the patient and indexed into the impression after assembly with an Implant Analog.

Impression coping is picked-up in the impression. An implant analog is attached to the incorporated coping before the stone model is created.

IndirectTransferCopingsPage �5

DirectPick-upCopingsPage �6

Direct Abutment Impression (Crown & Bridge-type)A crown & bridge impression is made of a seated abutment and a stone model is created. The abutment remains in place during laboratory fabrication of the final prosthesis.

Implant-level Closed-tray Transfer (Non-hex engaging)Impression coping remains in mouth when impression tray is removed. Coping is transferred from the patient and indexed into the impression after assembly with an Implant Analog.

IndirectTransferCopingsPage �5

Multiple-unitsonly

IMPRESSIONCOMPONENTOVERVIEW

AbutmentsforCement-retentionPages ��-��

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Abutment for Screw-level Closed-tray Transfer

Abutment for Screw-level Open-tray Pick-up

AbutmentforScrew-levelIndirectTransferCopings

Page �9Impression copings remain in mouth when the tray is removed. Copings are transferred from the patient and seated in the impression after assembly with Abutment for Screw Analogs.

Impression copings are picked-up in the impression. Abutment for Screw Analogs are attached to the incorporated copings and a stone model is poured.

BallAbutmentImpressionComponentsPages �0-��

Ball Abutment Closed-tray TransferAn impression is made of the seated Ball Abutments which remain in place when the tray is removed. Ball Abutment Analogs are seated in the impression and a stone model is poured.

AbutmentforScrew-levelDirectPick-upCopings

Page �9

IMPRESSIONCOMPONENTOVERVIEW

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Ø6.25mm

1.5mm

5.2mm

Ø5.75mmØ4.5mm

8mm

�.5mm 3inOne Abutment

�.0mm 3inOne Abutment

5.0mm 3inOne Abutment

6.0mm 3inOne Abutment

•Forcement-retained,single-ormultiple-unitprostheses•IncludesAbutmentScrew(130-300or140-300,finaltorque:30Ncm)•UsedwithBall-topScrewasaclosed-tray,hexed-timedimpressioncoping•Gold-coloredTitaniumNitride[TiN]coatingfortissueesthetics•Titaniumalloy[Ti-6Al-4V]

�0�-��

�0�-��

�05-5��

�06-6��

Ø5.25mm

6° 8° 10° 15°

Ø3.2mmØ3.2mmØ3.2mmØ2.9mm

�.5mm Ceramic Abutment

�.0mm Ceramic Abutment

5.0mm Ceramic Abutment

6.0mm Ceramic Abutment

•Forsingle-ormultiple-unitprosthesesintheanteriorestheticzone•IncludesAbutmentScrew(130-400or140-400,usedonlywith

ExternalCeramicAbutments,finaltorque:30Ncm)•Yttria-stabilizedZirconia[ZrO2]

��-��5

��-��5

��5-��5

��6-��5

Ø7.7mm

2.0mm

Ø6.6mmØ5.1mm

5°

7mm*

Ø5.6mm

5mm

5° 5° 8°


RESTORATIVECOMPONENTS

3inOneAbutmentsforCement-retainedRestorations

CeramicAbutmentsforEstheticZoneRestorations

*Previous versions of these abutments were 10mm high. Reduce as necessary using a low-speed handpiece at 15,000-20,000 RPM with a ceramic trimming wheel. Dipping both the wheel and abutment in water at frequent intervals during modification will help minimize heat generation.

�9

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1mm

15°

3mm

15°15°

�.5mm Angled Esthetic Abutment

�.0mm Angled Esthetic Abutment

5.0mm Angled Esthetic Abutment

•Forcement-retained,single-ormultiple-unitprostheses•IncludesAbutmentScrew(130-300or140-300,finaltorque:30Ncm)•Gold-coloredTitaniumNitride[TiN]coatingfortissueesthetics•Titaniumalloy[Ti-6Al-4V]

��-��

��-��

��5-��

9mm

�.5mm Straight Esthetic Abutment

�.0mm Straight Esthetic Abutment

5.0mm Straight Esthetic Abutment

•Forcement-retained,single-ormultiple-unitprostheses•IncludesAbutmentScrew(130-300or140-300,finaltorque:30Ncm)•Gold-coloredTitaniumNitride[TiN]coatingfortissueesthetics•Titaniumalloy[Ti-6Al-4V]

��-��

��-��

��5-��

1mm

Ø6.5mm

3mm

Ø5.9mmØ5.8mm

9mm

Ø6.5mmØ5.9mmØ5.8mm


AngledEstheticAbutmentsforCement-retainedRestorations

StraightEstheticAbutmentsforCement-retainedRestorations

�0

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�.5mm Angled Abutment

�.0mm Angled Abutment

5.0mm Angled Abutment

•Forcement-retained,single-ormultiple-unitprostheses•IncludesAbutmentScrew(130-300or140-300,finaltorque:30Ncm)•Titaniumalloy[Ti-6Al-4V]

��-�00

��-�00

��5-�00

1mm

17°

Ø3.7mm

11mm

Ø4.2mm Ø5.2mm

20° 20°


�.5mm Straight Abutment

�.0mm Straight Abutment

5.0mm Straight Abutment

��-��0

��-��0

��5-��0

4mm

10mm

3°

Ø3.7mm Ø4.2mm Ø5.2mm

4° 8°


AngledAbutmentsforCement-retainedRestorations

StraightAbutmentsforCement-retainedRestorations

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�.5mm Profile Abutment

�.0mm Profile Abutment

5.0mm Profile Abutment


��-��

��-��

��5-��

3mm

Ø5.8mm

12mm

Ø6.8mm Ø7.4mm

4mm

•Forcement-retainedmultiple-unitprostheses(finaltorque:30Ncm)•Bestsuitedforrestorationsrequiringonlyminorintra-oralmodification•One-piece,non-hexengagingabutment•Titaniumalloy[Ti-6Al-4V]

�.5mm Abutment for Cement, Non-hexed

�.0mm Abutment for Cement, Non-hexed

5.0mm Abutment for Cement, Non-hexed

��-�0�

��-�0�

��5-�0�

4°

Ø3.7mm

8mm

Ø4.2mm Ø5.2mm

6° 9.5°


ProfileAbutmentsforCement-retainedRestorations

AbutmentsforCement-retainedRestorations-Non-hexed

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•Forsingle-ormultiple-unitscrew-retainedorcustomabutmentcement-retainedrestorations

•IncludesAbutmentScrew(130-300or140-300,finaltorque:30Ncm)•Goldalloybase(60%Gold,20%Palladium,19%Platinum,1%Iridium)

withDelrin®burn-outsleeve•Dimensionsshownbelow

�.5mm Plastic Custom Castable Abutment, Hexed

�.0mm Plastic Custom Castable Abutment, Hexed

5.0mm Plastic Custom Castable Abutment, Hexed

6.0mm Plastic Custom Castable Abutment, Hexed

��-��7

��-��7

��5-��7

��6-��7

•Forsingle-ormultiple-unitscrew-retainedorcustomabutmentcement-retainedrestorations

•IncludesAbutmentScrew(130-300or140-300,finaltorque:30Ncm)•Delrin®burn-outsleeve•Dimensionsshownonoppositepage

�.5mm Gold/Plastic Custom Castable Abutment, Hexed

�.0mm Gold/Plastic Custom Castable Abutment, Hexed

5.0mm Gold/Plastic Custom Castable Abutment, Hexed

6.0mm Gold/Plastic Custom Castable Abutment, Hexed

��-��7

��-��7

��5-��7

��6-��7

HexedandNon-hexedGold/PlasticCustomCastableAbutmentsshareidenticalexternalgeometry.

Ø6.75mm

1mm

Ø6.0mmØ4.5mm

12mm

Ø5.0mm

5mm (top of alloy base)


CustomCastable(UCLA)Abutments-Hexed

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�.5mm Gold/Plastic Custom Castable Abutment, Non-hexed

�.0mm Gold/Plastic Custom Castable Abutment, Non-hexed

5.0mm Gold/Plastic Custom Castable Abutment, Non-hexed

6.0mm Gold/Plastic Custom Castable Abutment, Non-hexed

�.5mm Plastic Custom Castable Abutment, Non-hexed

�.0mm Plastic Custom Castable Abutment, Non-hexed

5.0mm Plastic Custom Castable Abutment, Non-hexed

6.0mm Plastic Custom Castable Abutment, Non-hexed

��-��0

��-��0

��5-��0

��6-��0

•Formultiple-unitscrew-retainedorcustomabutmentcement-retainedrestorations

•IncludesAbutmentScrew(130-300or140-300,finaltorque:30Ncm)•Delrin®burn-outsleeve•Dimensionsshownbelow

��-��

��-��

��5-��

��6-��

•Formultiple-unitscrew-retainedorcustomabutmentcement-retainedrestorations

•IncludesAbutmentScrew(130-300or140-300,finaltorque:30Ncm)•Goldalloybase(60%Gold,20%Palladium,19%Platinum,1%Iridium)

withDelrin®burn-outsleeve•Dimensionsshownonoppositepage

HexedandNon-hexedPlasticCustomCastableAbutmentsshareidenticalexternalgeometry.

Ø6.75mm

0.5mm

Ø5.75mmØ4.2mm

12mm

Ø4.75mm


CustomCastable(UCLA)Abutments-Non-hexed

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�.5mm PEEK Temporary Abutment

�.0mm PEEK Temporary Abutment

5.0mm PEEK Temporary Abutment

6.0mm PEEK Temporary Abutment

•Forcement-orscrew-retainedprovisionalrestorations(upto30days)•IncludesAbutmentScrew(130-300or140-300,hand-tighten)•DirectCopingScrews(purchaseseparately,page27)maybeusedtomaintain

screwaccessholeduringfabricationofscrew-retainedprovisionalrestorations•PEEK®(PolyEtherEtherKetone)material

�7�-000

�7�-000

�75-000

�76-000

Ø6.5mm

3.0mm

Ø6.0mmØ4.75mm

4°

8mm

Ø5.5mm

5mm

5° 5° 7°


0.5mm

Ø4.2mm

9mm

Ø4.75mm Ø5.75mm

�.5mm Titanium Temporary Abutment, Hexed

�.0mm Titanium Temporary Abutment, Hexed

5.0mm Titanium Temporary Abutment, Hexed

��-��5

��-��5

��5-��5

•Forsingle-unit(hexed)ormultiple-unit(non-hexed)screw-retainedprovisionalrestorations•IncludesAbutmentScrew(130-300or140-300,hand-tighten)•DirectCopingScrews(purchaseseparately,page27)maybeusedtomaintainscrew

accessholeduringfabricationofscrew-retainedprovisionalrestorations•TitaniumAlloy[Ti-6Al-4V]

�.5mm Titanium Temporary Abutment, Non-hexed

�.0mm Titanium Temporary Abutment, Non-hexed

5.0mm Titanium Temporary Abutment, Non-hexed

��-��

��-��

��5-��


PEEK®TemporaryAbutments

TitaniumTemporaryAbutments

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�.5mm Ball-top Screw

�.0/5.0/6.0mm Ball-top Screw

��-��5

��-��5

The Ball-top Screw MUST be used with

a 3inOne Abutment to serve as an

indirect transfer coping

11mm

3mm

8mm

Ø4mm

5°

Ø3.7mm

10mm

Ø4.2mm Ø5.2mm

5° 7°

•Onlyusedforclosed-tray,non-hexedtransferswhenthefinalrestorationistobeamultiple-unit,non-hexengaging,screw-retainedprosthesis,orformakingimpressionsforfabricationofacustomimpressiontray

•Hand-tightenmanuallyorwiththe.050”(1.25mm)HexDriver•TitaniumAlloy[Ti-6Al-4V]

�.5mm Indirect Transfer Coping, Non-hexed

�.0mm Indirect Transfer Coping, Non-hexed

5.0mm Indirect Transfer Coping, Non-hexed

��-�00

��-�00

��5-�00

IMPRESSIONCOMPONENTS

Ball-topScrewforIndirectTransfer

IndirectTransferCopings(ClosedTray)-Non-hexed

•Usedwiththe3inOneAbutmentasanimpressioncopingforclosed-trayindirecttransfers

•Screwsfor3.5mmimplants(213-235)areyellow(anodized)•Screwsfor4.0/5.0/6.0mmimplants(214-235)aresilver(un-anodized)•Hand-tightenmanuallyorwiththe.050”(1.25mm)HexDriver•TitaniumAlloy[Ti-6Al-4V]

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Direct Pick-up Copings (Open Tray) - Non-hexed

•Usedtomakeanopen-tray,implant-level,hexed-timedimpression•PackagedwiththeextendedDirectCopingScrew(243-320or244-320)•TitaniumAlloy[Ti-6Al-4V]

•Usedtomakeanopen-tray,implant-level,non-hexedimpression•PackagedwiththeextendedDirectCopingScrew(243-320or244-320)•TitaniumAlloy[Ti-6Al-4V]

��-��

��-��

��5-��

��6-��

�.5mm Direct Pick-up Coping, Non-hexed

�.0mm Direct Pick-up Coping, Non-hexed

5.0mm Direct Pick-up Coping, Non-hexed

6.0mm Direct Pick-up Coping, Non-hexed

�.5mm Direct Pick-up Coping, Hexed

�.0mm Direct Pick-up Coping, Hexed

5.0mm Direct Pick-up Coping, Hexed

6.0mm Direct Pick-up Coping, Hexed

��-��

��-��

��5-��

��6-��

Ø6.2mm

5mm

Ø3.7mm

11mm

Ø4.2mm Ø5.2mm

6mm

17mm

Ø2.5mm


DirectPick-upCopings(OpenTray)-Hexed

DirectPick-upCopings(OpenTray)-Non-hexed

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•Packagedwithallimplantsandtwo-pieceabutments•Screwsfor3.5mmimplants(130-300)areyellow(anodized)•Screwsfor4.0/5.0/6.0mmimplants(140-300)aresilver(un-anodized)•Utilizesthe.050”(1.25mm)HexDriver(finaltorque:30Ncm)•TitaniumAlloy[Ti-6Al-4V]

•PackagedwithallDirectPick-upCopings•Screwsfor3.5mmimplants(243-320)areyellow(anodized)•Screwsfor4.0/5.0/6.0mmimplants(244-320)aresilver(un-anodized)•Maybeusedextrascrewlengthisneeded,ortomaintainscrewchannel

duringfabricationofscrew-retainedprovisionalprostheses•Utilizesthe.050”(1.25mm)HexDriver.Hand-tightenortorqueto30Ncm

dependingonapplication•TitaniumAlloy[Ti-6Al-4V]

�.5mm Direct Pick-up Screw

�.0/5.0/6.0mm Direct Pick-up Screw

��-��0

��-��0

�.5mm Abutment Screw

�.0/5.0/6.0mm Abutment Screw

��0-�00

��0-�00

•RepresentstheExternalimplantinalaboratory-fabricated,implant-levelstonemodel

•Color-codedbyimplantbodydiameter•TitaniumAlloy[Ti-6Al-4V]

�.5mm Implant Analog

�.0mm Implant Analog

5.0mm Implant Analog

6.0mm Implant Analog

�9�-000

�9�-000

�95-000

�96-000


DirectCopingScrews

AbutmentScrews

ImplantAnalogs

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UsedtoretainbarsorprosthesesfabricatedfromthePlasticCopingsforAbutmentforScrew.Utilizesthe.050”(1.25mm)HexDriver.Finaltorque:30Ncm.TitaniumAlloy[Ti-6Al-4V].

�.5mm Abutment for Screw, �mm collar


�.5mm Abutment for Screw, 5mm collar



�.0mm Abutment for Screw, 5mm collar

5.0mm Abutment for Screw, �mm collar

5.0mm Abutment for Screw, �mm collar

5.0mm Abutment for Screw, 5mm collar

�5�-�0�

�5�-�0�

�5�-�05

�5�-�0�

�5�-�0�

�5�-�05

�55-�0�

�55-�0�

�55-�05

Burn-outcoping(matrix)forAbutmentforScrew.Maybetrimmedforheight.CopingScrewsmustbepurchasedseparately(below).Delrin®.

�.5/�.0mm Plastic Coping, Abutment for Screw (5 pack)

5.0mm Plastic Coping, Abutment for Screw (5 pack)

�5�-��0

�55-��0

Usedinthelabwhenalongerscrewisdesired.UsedonlywiththeAbutmentforScrew.Hand-tightenortorqueto30Ncmdependingonapplication.TitaniumAlloy[Ti-6Al-4V].

Long Bar Retention Coping Screw, Abutment for Screw (5 pack)

��-��Short Bar Retention Coping Screw, Abutment for Screw (5 pack)

��-��0

Ø5.2mm

12mm

��-500 (2.7mmhigh)

�5�-��0 �55-��0

3,4or5mm

Ø4.2mm

1.25mm

Ø3.7mm

Ø4.2mm

Ø4.2mm Ø5.2mm

Ø5.2mm

Ø4.2mm

4.5mm

ABUTMENTSFORSCREWANDCOMPONENTS

AbutmentforScrew

PlasticCopings,AbutmentforScrew

Screws,AbutmentforScrew

•Formultiple-unitrestorationsincluding:abutment-levelscrew-retainedrestorations,castalloybarsforoverdenturesandfixed/detachable(hybrid)restorations

•PackagedwiththeCoverCap(224-500)•SeatusingtheappropriateHexAdapter,AbutmentforScrew

(purchasedseparately,page29)•TitaniumAlloy[Ti-6Al-4V]

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PackagedwithallAbutmentsforScrew.Hand-tightenwith.050”(1.25mm)HexDriver.TitaniumAlloy[Ti-6Al-4V].

��-500 Cover Cap, Abutment for Screw

Usedtomakeadirectpick-upimpression(open-tray)attheabutmentlevel.Packagedwiththerequiredscrew.UsedonlywiththeAbutmentforScrew.TitaniumAlloy[Ti-6Al-4V].

Usedtomakeanindirecttransfer(closed-tray)impressionattheabutmentlevel.UsedonlywiththeAbutmentforScrew.TitaniumAlloy[Ti-6Al-4V].

UsedtorepresenttheAbutmentforScrew/Implantassemblyintheworkingcast.Notforusewithimplant-levelimpressions.TitaniumAlloy[Ti-6Al-4V].

�.5/�.0mm Analog, Abutment for Screw

5.0mm Analog, Abutment for Screw

�5�-600

�55-600

RequiredforplacementofAbutmentforScrew.MaybedrivenbyeitherHandWrench,TorqueWrenchorAS123HandUnit.

�.5/�.0mm Hex Adapter, Abutment for Screw

5.0mm Hex Adapter, Abutment for Screw

�0�-��0

�05-��0

�.5/�.0mm Indirect Transfer Coping, Abutment for Screw

5.0mm Indirect Transfer Coping, Abutment for Screw

�5�-�00

�55-�00

�.5/�.0mm Direct Pick-up Coping, Abutment for Screw

5.0mm Direct Pick-up Coping, Abutment for Screw

��-��

��5-��

ABUTMENTFORSCREWCOMPONENTS

DirectPick-upCopings,AbutmentforScrew

IndirectTransferCopings,AbutmentforScrew

Analogs,AbutmentforScrew

CoverCap,AbutmentforScrew

HexAdapter,AbutmentforScrew

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2,4or6mm

3.5mm

Ø2.5mm

Ø3.7mm Ø4.2mm Ø5.2mm

Ø5.9mm

2.6mm5mm

Ø5.5mm

3.2mm

O-Ring Attachment SetO-Ringencapsulator2ProcessingO-rings2ClinicalO-rings

�60-�00

StandardO-ringattachmentforprocessingintodenture.

O-Ring Encapsulator Femalereceptacleprocessedintodenture.Titanium.2perpackage.

�60-�00

Clinical O-RingUsedforclinicalapplications.Silicone.12perpackage.

�60-��0

Processing O-RingUsedforlabprocessingapplications.Buna.12perpackage.

�60-��0

�.5mm Ball Abutment, �mm Collar


�.5mm Ball Abutment, 6mm Collar



�.0mm Ball Abutment, 6mm Collar

5.0mm Ball Abutment, �mm Collar

5.0mm Ball Abutment, �mm Collar

5.0mm Ball Abutment, 6mm Collar

�6�-00�

�6�-00�

�6�-006

�6�-00�

�6�-00�

�6�-006

�65-00�

�65-00�

�65-006

BALLABUTMENTSANDCOMPONENTS

BallAbutments

O-ringAttachmentSystem

•Forretentionoftissue-supportedoverdentures•UsewiththeBallAttachmentorO-ringAttachmentsystem•Recommendedforrelativelyparallelimplants•Seatwith.050”(1.25mmHexDriver(finaltorque:30Ncm)•TitaniumAlloy[Ti-6Al-4V]

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�60-�00

�60-500

�.5/�.0mm Ball Abutment Analog (� pack)

5.0mm Ball Abutment Analog (� pack)

Set of � toolsInsertSeatingTool,ReamerandParallelingTool.

BCS

TheBallAttachmentsystemoffersseveraladvantagesovertraditionalO-ringattachments.Itrequireslessmesial/distal/buccal/lingualspaceandoffersfourdifferentlevelsofretention.Thenylonretentioninsertscanbechangedchairside.

Pink Nylon Insert Clinicaluse.2perpackage.SoftRetention:2.3lb/875g

White Nylon Insert Clinicaluse.2perpackage.StandardRetention:3.3lb/1250g

Yellow Nylon Insert Clinicaluse.2perpackage.ExtraSoftRetention:1.4lb/525g

Black Nylon Insert LabProcessingandChair-sideDenturePick-up.2perpackage.

Green Nylon Insert Clinicaluse.2perpackage.ElasticRetention.

BCIG

BCIB

BCIY

BCIW

Directional RingsUsedforobtainingparallelism.0°,7°and14°rings.Setof3.

BCDR

BCIP

Castable Ball Pattern Burn-outcomponentforfabricationofacustombarwithballattachments.Not recommended for use with O-Ring Attachments.2ballsperpattern.

BCIST Paralleling ToolAlaboratorytoolusedonasurveyortopositionandwaxcastableballsonabar.

ReamerUsedtoadjustretentionofnyloninserts.

BCR

BCPTInsert Seating ToolUsedtoseatnyloninsertsinattachmenthousings.

BCCBP

BCAHT

Includes:(1)TitaniumHousing,(3)FemaleNylonInserts-white(moreretention),pink(lessretention),black(labprocessing)and(1)ProtectiveDisk(ref.BCPD,protectstissueduringimpressionmakingordenturepick-up)

BCAS Ball Attachment Set

BALLABUTMENTCOMPONENTS

BallAttachmentSystem

BallAbutmentAnalogs

Attachment Housings - TitaniumForResinpickuporSoldering.2perpackage.

UsedtorepresenttheBallAbutment/Implantassemblyintheworkingcast.OnlyusedinconjunctionwithBallAbutments.TitaniumAlloy[Ti-6Al-4V].

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Hand WrenchUsedondriveendofAS123HandUnit.AlsofitsindividualHexDrivers/AdaptersandBoneTaps.

�00-�00

�0 Ncm Torque WrenchUsedtodelivertorquetoprostheticcomponents.

�00-070

�00-�00 AS�� Hand UnitProvidesimprovedvisionandeasyaccesstoprostheticcom-ponentsinposteriorregionsofthemouth.HandWrenchandDriversmustbepurchasedseparately.

Mayalsobepurchasedaspartofthe320-000CompleteProstheticInstrumentationSystem(seeabove).

Prosthetic Sterilization Tray (not shown)Autoclavabletrayforprostheticinstrumentation(includedwiththe320-000and320-101).

Complete Prosthetic Instrumentation System (shown)Includes:AS123HandUnit/HandWrench/30NcmTorqueWrench/.050”(1.25mm)HexDriver,Regular/.050”(1.25mm)HexDriver,Long/HexAdaptersforAbutmentforScrew/RatchetExtender/SterilizationTray.

��0-000

.050” (�.�5mm) Hex Driver Regular or LongUsedtodriveallsurgicalandprostheticcomponentswiththeexceptionoftheAbutmentforScrew.

�00-�50 (regular)

�00-�5� (long)

6.25mm12.5mm

��0-�0� Basic Prosthetic Instrumentation Kit (not shown)Includes:HandWrench/30NcmTorqueWrench/.050”(1.25mm)HexDriver,Regular/.050”(1.25mm)HexDriver,Long/RatchetExtender/SterilizationTray.

ProstheticInstrumentationSystem

RequiredforplacementofAbutmentforScrew.MaybedrivenbyeitherHandWrench,TorqueWrenchorAS123HandUnit.

�0�-��0

�05-��0

�.5/�.0mm Hex Adapter, Abutment for Screw

5.0mm Hex Adapter, Abutment for Screw

PROSTHETICINSTRUMENTATION

�00-��0

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IMPAH Abutment Clamp

Usedtoholdtwo-pieceabutmentsduringdeliveryandtighteningoftheAbutmentScrew.AbutmentClamp

ExternalImplantAnalogHandles

ForinstallationandremovalofCoverScrews,HealingAbutmentsandAbutmentScrews.TheHandpieceHexDriversareusedwithlatch-typecontra-anglehandpieces.TheHandpieceHexDriver,Long(134-450)is5mmlongerthanthestandardversion(134-350).

��5-�5�

��-�50

��-�50

.050” (�.�5mm) One-piece Hex Driver

.050” (�.�5mm) Handpiece Hex Driver

.050” (�.�5mm) Handpiece Hex Driver, Long

Clean-outTapTools

HexDrivers

�.5mm Implant Clean-out Tap Tool

�.0/5.0/6.0mm Implant Clean-out Tap Tool

Abutment for Screw Clean-out Tap Tool

Usedtore-threadExternalimplantsorAbutmentsforScrewwheretheinternalthreadshavebecomedamaged.RequiresastandardsurgicalRatchet(130-000)orHandWrench(300-400)asadrivemechanism.

��-00�

��-00�

��-�70

UsedtoholdExternalabutmentsforchairsideorlaboratorypreparation,thesehandlesmimictheimplant/analoghexgeometry.AbutmentsaresecuredtothehandlewiththestandardAbutmentScrew.Comesinthreeplatformsizes:Ø3.5,4.0mmandØ5.0/6.0mm.

�.5mm Implant Analog Handle

�.0mm Implant Analog Handle

5.0/6.0mm Implant Analog Handle

�9�-�00

�9�-�00

�95-�00

ANCILLARYPROSTHETICINSTRUMENTATION

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ML0�� Patient Education – Tooth Replacement with Dental Implants posterThis2-sidedlaminatedpostervisuallyoutlinestheadvantagesofimplanttherapycomparedtotraditionaltreatmentmethods.Onesidefocusesontoothreplacementoptions,whiletheoppositesidecontainsinformationonbonelossandhowdentalimplantscanhelppreservebone.Twopostersperpackage.24”x36”(61cmx91cm).

Five Implant Acrylic ModelThislife-sizedmodelallowsthecliniciantoillustrateimplantplacementofBioHorizonsimplants.Clearacrylicallowstheimplantstobeviewedinrelationtoadjacentteeth.Callforavailability.

MPSA

ML0�� Patient Education – Dental Implants - the tooth replacement solutionThishigh-qualityflipbookhelpstheimplantcandidateunderstandtherationaleandtheadvantagesofimplanttherapycomparedtotraditionaltreatmentmethods.Themessagefocusesonthepositivesofimplantsandtheirabilitytogreatlyreducethebonelossassociatedwithedentulism.Manytreatmentoptionsaredetailedtoaidtheclinicianindescribingaprocedure.9”x6”(23cmx16cm).

ML0�0�

ML0��

ML0��9

MLD�0� Patient Education – Soft tissue grafting with AlloDerm Thisbrochurehelpspatientswithrecedinggumtissueand/orsensitiverootsunderstandthebasicscience,safety,andbenefitsoftissuegraftingwithAlloDermRegenerativeTissueMatrix.8.5”x3.5”(21.5cmx8.7cm).

Patient Education – Rebuilding and maintaining bone Thisbrochureexplainsthebenefitsandbasicscienceofboneregenerationanditsrelationshiptoimplanttherapy.8.5”x3.5”(21.5cmx8.7cm).

Patient Education – Stabilizing dentures using dental implantsThisbrochurehelpsthedenturewearerunderstandtherationaleandtheadvantagesofdenturestabilizationwithimplants.8.5”x3.5”(21.5cmx8.7cm).

Patient Education – Tooth replacement with dental implants Thisfour-foldbrochurehelpstheimplantcandidateunderstandtherationaleandtheadvantagesofimplanttherapycomparedtotraditionaltreatmentmethods.Themessagefocusesonthepositivesofimplantsandtheirabilitytogreatlyreducethebonelossassociatedwithedentulism.8.5”x3.5”(21.5cmx8.7cm).

External �x Patient Education Model This4-timesscalemodelincludestheImplant,Abutment,AbutmentScrew,Ball-topScrew,HealingAbutment,CoverScrew,ImplantDriverandHexDriver.Excellentfordemonstratingimplantcomponentstothepatient.Callforavailability.

M�XIM

PATIENTEDUCATIONMATERIAL

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This Surgical Manual serves as a reference for using BioHorizons External implants and surgical instruments. Its sole

intentionistoprovideinstructionsontheuseofBioHorizonsproducts.Itisnotintendedtoprovideinstructiononmethods

orproceduresfordiagnosis,treatmentplanning,orplacementofimplants;nordoesitreplaceclinicaltrainingoraclinician’s

bestjudgmentregardingtheneedsofeachpatient.BioHorizonsstronglyrecommendsappropriatetrainingasaprerequisite

fortheplacementofimplantsandassociatedtreatment.

The procedures illustrated and described within this manual reflect idealized patient presentations with adequate bone

andsofttissuetoaccommodateimplantplacement.Noattempthasbeenmadetocoverthewiderangeofactualpatient

conditionsthatmayadverselyaffectsurgicalandprostheticoutcomes.Clinicianjudgmentasrelatedtoanyspecificcase

mustalwayssupersedeanyrecommendationsmadeinthisoranyBioHorizonsliterature.

BeforebeginninganyimplantsurgicalprocedurewithBioHorizonsimplants:

•Designasurgicaltreatmentplantosatisfytheprostheticrequirementsofthecase.

•ReadandunderstandtheInstructionsforUsethataccompanytheproducts.

•Cleanandsterilizethesurgicaltrayandinstrumentsperinstructions.

•Becomethoroughlyfamiliarwithallinstrumentsandtheiruses.

•StudySurgicalKitlayout,color-codingschemeandiconography.

TreatmentPlanning

Theimplantteamshouldbeinagreementandincommunicationthroughoutallstagesoftherapy.Thepatient,therestorative

andsurgicaldoctors,aswellasthedentallaboratoryshouldunderstandandagreeuponthetreatmentplan.Thetreatment

planshoulddeterminethedesign,numberandpositionoftheimplants.

DiagnosticCasts

Mountedstudycastsandadiagnosticwax-uparethefoundationfordeterminingimplantposition. SurgicalGuideTemplates

Oncethediagnosticwax-upisfinalized,therestorativedoctorordentallaboratoryfabricatesthesurgicalguidetemplate.

Thisguideindicatestothesurgeontheimplantpositionthatoffersthebestsupportfortheprosthesis,aswellasoptimal

estheticsandhygienerequirements.Thesurgicalguidealsoprovidesinformationaboutthetoothandsupportingstructures

thathavebeenlost.

LaboratoryGuideTemplates

Amatrixofthediagnosticwax-upmayalsobeutilizedbythelaboratorywhendevelopingthefinalprosthesis.Thematrix

actsasaguideforpositionandcontouroftheprosthesis.

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LEXTERNALSURGICALMANUAL-INTRODUCTION

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•Packagedwith3inOne Abutment,AbutmentScrewandCoverScrew

•Machinedcollar:0.5mmhigh

•Bodydiameters:3.5mm/4.0mm/5.0mm/6.0mm

•Implantlengths:9mm/10.5mm/12mm/15mm

•Prostheticplatforms0.2mmwiderthanimplantbody

•ChoiceofRBTorHAsurface(HAnot offered on Ø3.5mm implants)

•TitaniumAlloy(Ti-6Al-4V)

Minimum ridge width

Implant body Diameter

Hex flat-to-flat measurement

Implant body lengths

Minimum mesial /distal space

Apical diameter

Prostheticplatform diameter

Allspacingrecommendationsgivenwithinthisliteraturearegeneralguidelines.Cliniciansmustapplytheirbestjudgementastowhethertheseguidelinesareappropriateforindividualpatientpresentations.

IMPLANTSPECIFICATIONS

3.5mm

9.0mm

9mm10.5mm12mm15mm

6.2mm

3.0mm

6.0mm

8.0mm

2.5mm

8.0mm

5.2mm

9mm10.5mm12mm15mm

3.0mm

5.0mm

7.0mm

2.1mm

7.0mm

4.2mm

9mm10.5mm12mm15mm

2.7mm

4.0mm

6.0mm

2.0mm

6.5mm

3.7mm

9mm10.5mm12mm15mm

2.4mm

3.5mm

5.5mm

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Two-stage Surgery was the original protocol developed for placingmoderndentalimplants.Theimplantisplacedbelowthesofttissueandprotectedfromocclusalfunctionandotherforcesduringosseointegration.Alow-profileCoverScrewisplacedontheimplanttoprotectitfromtheingressofsofttissue.

Following osseointegration, a second surgery exposes the implant anda transmucosal Healing Abutment is placed to allow soft tissue healing.Prostheticrestorationbeginsaftersofttissuehealing.

Single-stageSurgery leavestheimplant/abutmentconnectionexposedto theoralcavityviaa removableHealingAbutment.Thiseliminates theneedforasecondsurgerytoexposetheimplant.Althoughtheimplantisnotinocclusalfunction,someforcescanbetransmittedtoitthroughtheexposedtransmucosalelement.

Prosthetic restoration begins following osseointegration of the implantandsofttissuehealing.

Single-stage Surgery with Non-functional Immediate Teeth providesthe patient a non-occlusal provisional prosthesis early in the treatmentplan. An abutment is placed on the implant at or shortly after surgery,andaprovisionalrestorationissecuredtoitwithtemporarycement.Theprovisionalcanhelpcontourthesofttissueprofileduringhealing.

Single-stageSurgerywithImmediateFunctionmaybepossibleingoodquality bone where multiple implants exhibiting excellent initial stabilitycanbesplintedtogether.Splintingimplantstogethercanofferasignificantbiomechanical advantage over individual, unsplinted crowns. Cliniciansmust evaluate the mitigating patient factors in each case to determinewhetherimmediatefunctionisappropriate.

HealingAbutmentasatransmucosalelement.

CoverScrewinasubmergedsurgicalprotocol.

Non-functionalprovisionalprosthesis.

Splintedprosthesisinimmediatefunction.

Non-functionalImmediateRestoration

Single-stageSurgery

Two-stageSurgery

ImmediateFunctionalRestoration

SURGICALPROTOCOLS

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SpacingconsiderationsforBioHorizonsExternalimplants:

•Properspacingisessentialforesthetics,bonemaintenanceandhygieneconsiderations

•Maintainaminimumof1.5mmfromadjacentteeth(contactatcresttotheedgeofimplant)

•Maintain3.0mmedge-to-edgespacingbetweenadjacentimplants

•Watchfortoothrootstippedorangledbeyondthecontactregionofthecrown

•Minimumspacingguidelinesareillustratedbelow(figures rounded up to the next 0.1mm)

1.5mm

3.3mm

Osteotomycenter3.3mmfrom

adjacenttooth

3.0mm

7.5mm

Theosteotomycenter-to-centermeasurementrequiredtomaintaina3.0mmedge-to-edgespacingbetweenExternalimplantsisderivedusingthefollowingcalculation:½[sumof2implantbodydiameters]+3.0mm.Thetablebelowliststhepermutations.

1.5mm

3.5mm


adjacenttooth

1.5mm

4.0mm


adjacenttooth

Measurementisdependentonthetwoimplantbodydiameters.

Ø5.0mm implantØ�.0mm implantØ�.5mm implant

Theosteotomycenterpointrequiredtomaintaina1.5mmimplant-to-toothspacingisderivedusingthefollowingcalculation:½[implantbodydiameter]+1.5mm.ThemeasurementsforthefourExternalimplantbodydiametersareshownbelow.

1.5mm

4.5mm


adjacenttooth

Ø6.0mm implant

Ø�.5mm

Ø�.0mm

Ø5.0mm

6.5mm

6.8mm

7.3mm 8.0mm

7.0mm

7.5mm

Ø5.0mmØ�.0mmØ�.5mm

Ø6.0mm 7.8mm 8.5mm8.0mm

Ø6.0mm

9.0mm

bodydiameter

IMPLANTSPACINGCONSIDERATIONS

Ø5.0mm implant Ø�.0mm implant

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Probetipmeasuresosteotomydepth.

Purpose:Multi-functioninstrumentforintraoralmeasurements.

•Ø2.0mmprobetipmeasuresosteotomydepthinmillimeterincrements

•Fivecentimetergraduatedruleronshaft

•Endmeasuresimplant-to-implantspacing,mesial/distalandbuccal/lingual

•Aidsimplantplacementadjacenttoanexistingtooth

Therectangularendofthetoolprovidesintraoralmeasurementsofbuccal/lingualandmesial/distalspace.

7mm

9mm

11mm

13mm

15mm

10mm

12mm

14mm

16mm

Usingtherectangularendasshownagainstanexistingcrowncenterstheosteotomyapproximately4.25mmfromthecontact.

Usefulformarkingcenter-to-centerimplantspacingontheridgepriortomultipleimplantplacement.

Center-to-centerimplantspacing

~4.25mm

IMPLANTSPACER/DEPTHPROBE

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•All implantsareshownat100%scaleand125%scale (forpanoramic radiography).Themagnification factorofpanoramicradiographytypicallyrangesfrom115%to135%.

•5mmcircularrepresentationsareshownat100%and125%fortheradiographicballtechnique.Thistechniqueusesradiographicmarkingballsembedded inaplastic templateprior to radiographicexaminationof thepatient.Thesemarkingballswillbevisibleontheradiographicimage.

• Measurements can be taken to determine the magnification factor of the radiograph and help the practitioner accuratelydeterminetheamountofavailableboneforimplantplacement.Thefollowingexampleshowsthecalculationofamagnificationfactorandthesubsequentdeterminationofavailableboneabovethemandibularcanal:

Step1.Theradiographicmarkingballhasaknowndiameterof5mm.

Step2.Themeasured(apparent)diameterofthemarkingballontheradiographis6mm.

Step3.Themagnificationfactoriscalculatedas:6÷5=1.2or120%.

Step4.Themeasured(apparent)distanceontheradiographbetweenthecrestoftheridgeandthesuperioraspectofthemandibularnervecanalis15mm.

Step5.Theactualdistancebetweenthecrestoftheridgeandthemandibularcanalwouldbecalculatedas:15mm÷1.2=12.5mm.

ExternalRadiographicTemplateREF#L0250Actualsize8.5”x11”(21.5cmx28cm)

Purpose:Aidsclinicianinpreoperativedeterminationofoptionsforimplantlengthanddiameter.

A �mm margin of safety should be factored into any treatment plan adjacent to a vital anatomic structure.

RADIOGRAPHICTEMPLATE

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External Implant Color-code

TheExternalSurgicalKitusesan intuitive layouttoguidethesurgeonthroughthe instrumentsequence.Thesequencebegins inthe upper left hand corner and works left-to-right and then down. Color-coded lines, instruments and grommets further aid ininstrumentselectionandidentification.

Priortouse,cleanandsterilizethesurgicaltrayandinstruments(seepage57)andstudytheSurgicalKitlayout,color-codingandiconography.Surgicalassistantsshouldalsobethoroughlyfamiliarwithallinstrumentsandtheiruses.

Ø4.0mmimplantbody

Ø5.0mmimplantbody

Ø6.0mmimplantbody

Ø3.5mmimplantbody

Ø3.5 Ø4.0 Ø5.0 Ø6.0

SURGICALKIT

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ThedepthmarksareconsistentthroughouttheStarterDrill,DepthDrillsandWidthIncreasingDrills.Thethickbandsareeachonemillimeterwide.Thinlinesareusedtomark7mmand11mm.

Peri-operativeoral rinseswitha0.12%ChlorhexidineDigluconatesolutionhavebeenshown tosignificantly lower theincidenceofpost-implantationinfectiouscomplications.8Apreoperative30-secondrinseisrecommended,followedbytwicedailyrinsesfortwoweeksfollowingsurgery.

Drillingmustbedoneunderaconstantstreamofsterileirrigation.Apumpingmotionshouldbeemployedtopreventover-heatingthebone.Surgicaldrillsandtapsshouldbereplacedwhentheyareworn,dull,corrodedorinanywaycompromised.BioHorizonsrecommendsthereplacementofdrillsafter12to20osteotomies.9ADrill-usageTrackingChartisavailablefromBioHorizonstoaidofficesinarchivingthisimportantinformation.

Thereisariskofinjurytothemandibularnerveassociatedwithsurgicaldrillinginlowerposteriorregions.Tominimizetheriskofnerveinjury,itisimperativetheclinicianunderstandthedrilldepthmarkingsinordertocorrelateimplantlengthwiththeactualdrillingdepthtoproducethedesiredverticalplacementoftheimplant.

ThedescriptionsoftheDrillsinthisliteraturearespecifictotheExternalSurgicalKit(ref.160-500)andDrillspurchased after June 30, 2007. If you possess previous BioHorizons Surgical Kits or Drills, please refer toimportantInstructionsforUseonpage58.

14mm

10mm

12mm

15mm

11mm

13mm

7mm

9mm

TheSurgicalDrillsincludedintheExternalSurgicalKitareexternallyirrigatedanddesignedtobeusedatspeedsof850-2,500rpm7withsteadysterileirrigation.Reduceddrillspeedmaybedesiredinsofterboneorasdrilldiameterincreases.

DrillingConsiderations

SURGICALDRILLS

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Depth Drill Sequence (in average bone density)

Ø5.0mm implant body

Ø�.0mm implant body

Ø�.5mm implant body

Crestal Bone Drills

(site specific)

Bone Taps(site specific)

Ø6.0mm implant body

Width IncreasingDrill Sequence

(in average bone density)

Handpiece/Ratchet Adapters and

Insertion Tools

INSTRUMENTSEQUENCEREVIEW

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Purpose:Extendlengthoflatch-typedrillsandburs.

•Adds16millimeterstooveralllengthofdrillsandburs

•Providesaccessbetweenlongcrowns

•Internalgeometryengagesdrill’slatchgeometry

•Compatiblewithlatch-typehandpieces,bursanddrills

•Chisel-tipdesigneliminates“skating”onosseouscrest

•Initiatesosteotomytoplanneddepth

•PreparessiteforParallelPins

Purpose:Initiateosteotomy.

OSTEOTOMYINITIALIZATION

Ø2.0mmStarterDrills

DrillExtender

StandardLengthDrill

ExtendedShankDrill

DrillExtenderwithStandardLengthDrill

+8mm

+16mm

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ParallelingPinsmaybeusedfollowingtheØ2.0mmStarterDrilltoevaluateanychangesneededtoimproveimplantangulationandposition.TheParallelingPinsareprovidedbothstraightandwitha20°angle.ThelargeendoftheParallelingPinmaybeusedaftertheosteotomyisenlargedtoØ2.5mm.

Radiographicevaluationoftheosteotomy’sproximitytoadjacentanatomycanbemadeusingthePinsasreference,howeverthelevelofradiographicmagnificationmustbetakenintoaccount.Dividethefeature’sapparentlengthontheimagebytheknownactuallengthtocalculatethemagnificationfactor(apparentlength÷actuallength=magnificationfactor).

Byexample:iftheshankmeasures10.5mmontheradiograph,themagnificationfactoris:10.5÷9=1.16or116%.ThereforeiftheParallelPinappearsontheradiographtobe4.0mmawayfromastructure,theactualdistanceis4.0mm÷1.16,or3.4mm.

•Providedstraightandwitha20°angle

•UsedafterØ2.0mmStarterDrillandØ2.5mmDepthDrills

•9mmshankforradiographicevaluationofproximitytoadjacentanatomy

•Hubdiameteris4.0mm

Purpose:Evaluationofosteotomypositionandangle.

Theradiographicmagnificationfactorisderivedbycomparingtheapparentlengthontheradiographtotheknownactuallength.

9.0mm

Ø2.0mm

Ø2.5mm

9.0mm

HubØ4.0mm

�0.5mm

�.0mm

PARALLELPINS

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•Efficientcuttinggeometrycollectsboneforautografting

•Offeredwithandwithoutlength-specificstops

•UseDrillwithoutdepthstopwhencounter-sinkingimplant

Ø2.5mmDepthDrillsareusedtoincreaseand/orsetthedepthandwidthoftheosteotomyfollowinguseoftheØ2.0mmStarterDrill.Theymayalsobethefirstdrillsusedtosettheosteotomydepthforimplantplacementinanextractionsocket.TherearefourØ2.5mmDepthDrillswithfixedDepthStopscorrespondingtothestandardplacementdepthsoftheimplants,aswellasonedrillwithoutadepthstop.

Depth Stop Drills - Fixedcircularringsactas“stops”topreventdrillingbeyondthepre-determineddepth(9mm,10.5mm,12mmor15mm).Thesedrillsshouldnotbeusedwhensubcrestalplacement(counter-sinking)oftheimplant’sprostheticplatform/CoverScrewisplanned.Preparationtothefulllengthpermittedbyadepthstopallowsplacementofthecorrespondingimplantasshownabove.Foraddedreferencethesedrillshavestandarddepthmarkingsbelowthestop.

Depth Drill without Stop - Thisdrillhasdepthmarksrangingfrom7mmto15mm(seepage42).Theclinicianmustmanuallystopthedrillattheplanneddepthbasedonthedepthmarksontheshaft.Thisdrillshouldbeusedifallorpartoftheimplant’sprostheticplatform/CoverScrewwillbeplacedsubcrestal.

Purpose:IncreaseosteotomydepthfollowinguseoftheØ2.0mmStarterDrill.

2.5x12mmDepthStopDrill

2.5mmDepthDrillwithoutStop

12mmlongExternalImplant

Ø2.5MMDEPTHDRILLS

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•Depth-markedforreference.Non-endcuttinggeometryforaddedsafety

•Efficientcuttinggeometrycollectsboneforautografting

•Color-codedbythesmallestdiameterimplantbodywithwhichitisused

Ø3.0mm

Purpose:Incrementallywidenstheosteotomywithoutcreatingexcessiveheat.

WidthIncreasingDrillsareusedtoincrementallywidentheosteotomyafterthedepthhasbeenestablishedwithaØ2.5mmDepthDrill.Thegradualremovalofbonereducesheatgenerationinthesurroundingtissue.Thecuttingflutesextendthelengthofthedrillbodyandcollectbonethatmaybesavedforintraoperativegraftingprocedures.

TheWidthIncreasingDrillsfeatureahighlyefficientcuttinggeometry.Thedrillslackend-cuttinggeometry,therebycreatingabuilt-instopindensebonethatcanassistthesurgeonbypreventingosteotomypreparationbeyondtheplanneddepth.

Variations inbonedensityorpossiblevoidsrequiresurgeonstoobservethedrill’sdepthmarkingsastheprimarydeterminantofdrillingdepth,ratherthanrelyingexclusivelyonthenon-endcuttinggeometrytostopthedrill.

IfaWidthIncreasingDrillfailstoreachtheplanneddepthasshownbythedepthmarks,usetheØ2.5mmDepthDrilltore-establishthedepthandrecommencetheWidthIncreasingSequencewiththeØ3.0mmWidthIncreasingDrill.

Ø3.4mm Ø4.4mmØ3.9mm Ø5.4mmØ4.9mm

WidthIncreasingSequenceforØ3.5mmImplantBody




Ø3.0-5.4MMWIDTHINCREASINGDRILLS

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TopofCoverScrewlevelwiththeosseouscrest

Prostheticplatformlevelwiththeosseouscrest

CrestalBoneDrillspreparedensecrestalbonetoreceivetheimplant’sflaredcrestmodule.Thecrestmoduleistheareabeneaththeprostheticplatformandabovetheimplantthreads.Thesedrillsaretypicallynotusedinsiteslackingcorticalboneatthecrest.

ThereareseveralsignificantcuttinglevelsontheCrestalBoneDrills(seetopright).Implantplacementatlevelsbetweenthoseshowninthetwoexamplesaboverequirethesurgeontouseaproportionatelyappropriateamountofthecuttinggeometry.

•PreparingtoLevel1allowsplacementoftheprostheticplatformlevelwiththecrest(Example1).

•PreparingtoLevel2allowsplacementoftheCoverScrewlevelwiththecrest,provided the osteotomy has been prepared to accommodate the additional depth(Example2).

Purpose:Preparesdenseosseouscresttofacilitatepressure-freeseatingoftheflaredcrestmodule.

Example2.Preparationtocuttinglevel2

Example1.Preparationtocuttinglevel1

Level2

Level1

•SiteSpecific.Indicatedwhendensecorticalboneispresentatcrest

•Roundednon-cuttinghubcentersdrillinosteotomy

•UsedfollowingthefinalWidthIncreasingDrillforeachimplant

•850-2,500rpmwithsteadyirrigation.7

Cuttinglevels

CRESTALBONEDRILLS

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•SiteSpecific.Nottypicallyusedinsoft(D3-D4)bone

•30rpmorless10

•Finalosteotomypreparationinstrumentpriortoimplantplacement

•SquaredriveshaftinterfaceswithRatchetandHandWrench

Theosteotomyshouldbetappedindensebonetopreparethesitetoaccepttheimplant’sthreadswithoutcreatingexcessivepressure.TheuseofaBoneTapmayalsobe indicated in lessdensebonewhenoneormoresidesof theosteotomy is incontactwithalateralplateofcorticalbone.

TheBoneTapsmaybedrivenwitheitheraHandpiece(Fig.1),Ratchet,HandWrenchorbytheBioHorizonsSurgicalDriver(purchasedseparately,ref.150-000).TheRatchetandHandWrenchExtender(Fig.2)maybeusedwhenadditionallengthisneeded.

PlacethetipoftheBoneTapintotheosteotomy,applyfirmapicalpressureandbeginrotatingslowlyinaclockwisedirection(30rpmor less is recommended).Whenthethreadsengage,allowthetapto feedwithoutexcessivepressure.Toremove,rotatetheBoneTapinacounter-clockwisedirection,allowingittobackoutoftheosteotomy.DonotpullontheBoneTaptoremoveitfromthesite.

Priortopublicationofthisliterature,BioHorizonsExternalImplantswereofferedinmultiplethreadpitches:D2,D3andD4.CliniciansplacingpreviouslypurchasedD2threadformimplantsinsitesrequiringtappingmustusethecorrespondingD2BoneTaps(availablethroughBioHorizonsCustomerCare).

TheD3BoneTapsprovidedintheExternalSurgicalKitMAYbeusedtopreparesitesforD4implants,aswellasD3implants.However,D3BoneTapsMAY NOTbeusedtopreparesitesforD2implants.

Purpose:Preparesdensecorticalboneforimplantthreads.

Figure �.Handpiece

Figure �.Ratchet&Extender

9mm

11mm

13mm

15mm

10mm

12mm

14mm

DetailofBoneTapdepthmarks

BONETAPS

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Bodydiameterandsurfacetreatmenticon Implantsurfacetreatment

anddimensions

PartNumber

LotNumber

ExpirationDate

External Hex

Implant System

L0123 Rev C

BioHorizons Implant Systems, Inc. Birmingham, AL 35244 USA

Implant Diam

eterThreadform

Se

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stru

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ns fo

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Insid

e

external

REF

LOT

Rx Onlydo not re-use

gamma irradiatedSTERILE R

expires

0473

YYXXXXX

YYYY-MM

manufacture dateYYYY-MM

4012D3External Hex ImplantØ4.0 x 12mmD3 Threadform, RBT

External Hex Implant

Ø4.0 x 12m

m, RBT

D3

Ø4.0

BioHorizonsExternal implantsareprovided indouble-layerpackaging(asdepictedbelow).Acardboardsleeveprotectsablisterpackthatcontainstheimplantinasterileinnervial.Onlythesterileinnervialshouldbeintroducedintothesterilesurgicalfield.Theblistertraylidhasmultiplepeel-and-sticklabelsforaffixingtothepatient’schart.Whenthelidoftheblistertrayisremoved,theimplantvialisexposedandmaythenbeplacedinthesterilefield.Whileholdingthevialinanuprightfashion,removethecapbyrotatingitinacounter-clockwisedirection.Theimplantcanthenberemovedfromthevialbyengagingthepremounted3inOneAbutmentwiththeappropriateAdapter.

External Hex Implant System

L0123 R

ev C

Bio

Horizons Im

pla

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yste

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, A

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5244 U

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Implant Diameter Threadform

See Instructions for Use Inside

exte

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REF

LOT

Rx

Onl

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gam

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STER

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man

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YY

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4012

D3

Exte

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Hex

Impl

ant

Ø4.

0 x

12m

mD

3 Th

read

form

, RB

T

External Hex Implant Ø4.0 x 12mm, RBT

D3Ø4.0

External Hex

Implant System

L0123 Rev C


Implant Diam

eterThreadform

Se

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Insid

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external

REF

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expires

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Ø4.0 x 12 m

m, RBT

D3

Ø4.0

External Hex

Implant System

L0123 Rev C


Implant Diam

eterThreadform

Se

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Insid

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external

REF

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expires

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Ø4.0 x 12 m

m, RBT

D3

Ø4.0

External Hex

Implant System

L0123 Rev C


Implant Diam

eterThreadform

Se

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Insid

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external

REF

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expires

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Ø4.0 x 12 m

m, RBT

D3

Ø4.0

External Hex

Implant System

L0123 Rev C


Implant Diam

eterThreadform

Se

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Insid

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REF

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Ø4.0 x 12 m

m, RBT

D3

Ø4.0

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ThedimpleontheAdaptersalignwithanyofthefourexternalflats

ontheabutment.

Abutment-levelAdaptersengagethe3inOneAbutment’s

externalsquare.

IMPLANTPICK-UP

•Premounted3inOneAbutmentservesasthesurgicaldrivemount

•O-ringsecuresimplantwhileitiscarriedtoosteotomy

•Electrichandpieceormanualinsertionoptions

•30rpmorless10

Purpose:Engagesthe3inOneAbutmentallowingtheimplanttobedrivenintotheosteotomy.

HandpieceandRatchetAdaptersengageExternalimplantsviathesquareonthecoronalaspectofthe3inOneabutment.RemovethecapfromtheinnervialandseatthechosenAdapter.RemovetheimplantfromthevialandcarryittotheosteotomyontheAdapter,takingprecautionsnottotouchtheimplantsurfaceduringthetransfer.

Placetheapexoftheimplantintotheosteotomy,applyfirmapicalpressureandbeginrotatinginaclockwisedirection(30rpmorless).Oncetheapicalthreadsengagethebone,allowtheimplanttofeedwithoutexcessivepressure.

Overtighteningthe implant intheosteotomymaycauseosseousmicrofractureorpressure-inducednecrosisoftheadjacentbone.ManualseatingviatheAdapterforRatchetmaybedesiredtogainatactilesenseoffinalimplantplacement.Iftoomuchresistanceisfeltduringinsertion,removetheimplantandrevisetheosteotomywiththeappropriateCrestalBoneDrillorBoneTapasdeemednecessarytoreduceinsertiontorque.

HandpieceandRatchetAdapters(Abutment-level)

5�


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ThestatedlengthofBioHorizonsExternalimplantsismeasuredfromtheapexoftheimplanttothetopoftheprostheticplatform(seepage2).Theplacementlevelshouldbedrivenbytheprostheticnecessitiesofeachcase.Contributingfactorsinclude:availableinter-occlusalspace,softtissuethicknessandplannedprosthesistype.

Preparingtheosteotomytothestatedimplantlength(e.g.10.5mmdeepfor10.5mmlengthimplants)allowsplacementoftheprostheticplatformlevelwiththecrest(shownatright). Iftheprostheticplatformistobecountersunkbelowthecrest,acorrespondingincreaseoftheosteotomydepthisrequired.

Clinicians may opt to leave a portion of the 0.5mm machined collar and/or crest modulesupracrestal,ifdoingsodoesnotcompromisetheimplant’sinitialstabilityandadequatesofttissuecoverageexists.Itisnotrecommendedtoplaceimplantsinafashionthatleavessurfacetreatedareas(RBT/HA)exposedtotheoralcavity.

IMPLANTPLACEMENT

ImplantPlacement

HexDrivertipdetail:Taperhelpssecurecomponents

HexDriverandAbutmentScrew/ComponentEngagement

ThetipsofBioHorizonsHexDriversareslightlytaperedtoallowafriction-fitengagementofmatingscrewsandcomponents.Thetaperallowsscrewstobecarriedtotherestorativesiteonthehexdriver.However,whilethetaperenhancesclinicalutility,itrequiresthedriverbeengagedtothefulldepthofthehexholebeforetorqueisapplied.Failuretofullyengagethehexmaycausestrippingofeitherthedriverorthescrew.Aglovedfingermaybeplacedonthetopofthedrivertoprovideapicalpressuretokeepthedriverfullyengaged.

Useofmagnificationmayberequiredtoverifytheabsenceofforeignmaterialinthehexhole.Ifaprovisionalprosthesiswasinplacepriortofinaltorquedelivery,removeallmaterialusedtoblockout thescrewaccesschannelprior toseatingthedriver.Adentalprobeorsimilarinstrumentmaybeusefulforremovingimpediments.

Properengagementminimizeslikelihoodofcomponentstripping.

Incompleteengagementincreaseslikelihoodofcomponentstripping.

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Toremovethe3inOneAbutmentengagetheAbutmentScrewwiththe.050”(1.25mm)HexDriver,apply firmapicalpressure to theHexDriverandrotatecounter-clockwiseuntilthescrewiscompletelydisengagedfromtheimplantbody.The3inOneAbutmentmaythenberemoved.

Insoftbone,orwhenthe implant lacks initialstability,anAbutmentClamp(ref. IMPAH,soldseparately)shouldbeusedtograsptheoutsideoftheabutmenttoprovidecounter-torqueduringlooseningoftheAbutmentScrew.

The 3inOne Abutment (and Abutment Screw) should be sanitized following standardclinicalprotocolandretainedwiththepatient’schart.Itcanlaterbeusedintheimpressionmakingprocedureandasatemporaryorfinalabutmentforcementretention.

Thelongestflatsurfaceontheexternalaspectofthe3inOneAbutmentisindexedtooneofthesixflatsoftheimplant’sexternalhexagon.Inmostcasesoneofthehexflatsshouldbeorientedtothefacialaspect,as itallowsforangulationcorrectionwithstockangledabutments.Placingthe longflatof the3inOneAbutmenttothefacialalso leavesmoreroomforporcelaininthatareaonthefinalprosthesis.

The implant’s rotational position can be adjusted followingremoval of the 3inOne Abutment using the Implant-levelInsertionsToolsasdescribedonpage54.

ABUTMENTREMOVAL

3inOneAbutmentRemoval

HexOrientation

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• Packagedwitheachimplantinthesterileinnervial

•Hand-tighten(10-15Ncm)11utilizing.050”(1.25mm)HexDriver

• Color-codedbyimplantbodydiameter

Purpose:Protectsprostheticplatformintwo-stage(submerged)surgicalprotocols.

Removethe3inOneAbutmentandthoroughlyirrigatetheinsideoftheimplanttoremovebloodandotherdebris.UnscrewtheCoverScrew(includedineach implantvial) fromitsholderandscrewit intothe implantusingthe .050”(1.25mm)HexDriver.Followingplacementof theCoverScrew, thesurgicalsiteshouldbe irrigatedandthesoft tissueadapted inanormalsurgicalfashion.TakeprecautionstopreventtheCoverScrewfrombeingaspiratedbythepatient.

INSERTIONTOOLS/COVERSCREWS

CoverScrews

•Maybeusedfollowingremovalofthe3inOneAbutment

•Offersanarrowerpathofinsertionandbetterclearancethanthe

3inOneAbutment/Abutment-levelAdapteroption

•SquaredriveshaftinterfaceswiththeRatchetandHandWrench

Therotationalposition(hexflatorientation)ortheplacementlevelofExternalimplantscanbeadjustedwiththeInsertionToolsfollowingremovalofthe3inOneAbutment.

MatetheappropriateInsertionToolwiththeexternalhexoftheimplantandlightlyscrewintoplace.EngagetheInsertionToolwitheithertheRatchetorHandWrenchandrotatetheimplanttotherequiredposition.

Purpose:Engagesexternalhexallowingimplant’spositiontobeadjustedintheosteotomy.

InsertionTools(Implant-level)

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L• Selectbyheightandemergenceprofile(seebelow)

•Hand-tighten(10-15Ncm)11utilizing.050”(1.25mm)HexDriver

• Color-codedbyimplantbodydiameter

• Encodedforeasyintraoralidentification,forexample:

� x �.5indicates�.0mmimplantdiameterx�.5mmhigh

Purpose:Transmucosalelementforsingle-stagesurgicalprotocolorforsofttissuehealing

periodfollowingsecond-stageuncovery.

HealingAbutmentsareplacedafteruncoveryinatwo-stagesurgicalprotocol,orin lieuofaCoverScrewinasingle-stage(non-submerged)protocol.ExternalHealingAbutmentsarespecifictoeachofthefourimplantbodydiametersandcomeinthreeheights(3mm,4.5mmand6mm)withthechoiceofstraightorflaredemergenceprofiles.Theheightshouldbechosensothatitextendsapproximately1mmthroughthesofttissue.

Following seating, irrigate the surgical site and adapt the soft tissue in normal surgical fashion. A gingivectomy or apicallypositionedflaptechniquemaybeusedtoreducethesofttissuethicknessandtodecreasesulculardeptharoundtheimplant.ThesuturegrooveontheHealingAbutmentmaybeusedtoapicallypositionthesofttissueflap.TakeprecautionstopreventtheHealingAbutmentfrombeingaspiratedbythepatient.

FlaredEmergenceProfileHealingAbutmentsshouldbeusedwheneveruseofanabutmentwithaflaredmarginisplannedandmesial/distalspacepermits.Theflaredprofilecontoursthetissueawayfromtheimplantprostheticplatformandallowseasierseatingofflaredabutments.FlaredEmergenceProfileHealingAbutments are approximately 1mm wider than the prosthetic platform of thecorrespondingimplant.

Straight Emergence Healing Abutments have the same diameter as thecorresponding implant platform. Proper seating of the 3inOne Abutment andother flared emergence abutments may be difficult if the Straight EmergenceHealingAbutmentisused.Inthesecases,the3inOneAbutmentshouldnotbeused as an impression coping. All other BioHorizons impression copings willworkforthesecases.Besurethatthecopingusedisappropriateforthespecificcase(hexedornon-hexed).

StraightEmergenceProfile

FlaredEmergenceProfile

HEALINGABUTMENTS

HealingAbutments

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Also called a “Go / No-Go Gauge,” the Bur Testing Gauge is used to verify the dimensionalaccuracy of drill shanks of latch-type burs. Burs in proper conditionWILL fit into the largerdiameterhole,butWILL NOT fitintothesmallerhole(markedred).

Bursthatfaileitherofthesecriteriaareunfitforuseandmaybecomestuckinthehandpieceifused.Thegauge is includedwithallW&Hstarterpackages,andmayalsobeorderedfrompage13.

BoneProfilersremoveandcontourexcessboneandsofttissuefromtheareaoftheprostheticplatformpriortotheseatingofahealingorprostheticabutment.ThereisaspecificBoneProfilerforeachofthefourimplantbodydiameters.

ThesurgicalCoverScrewalignstheBoneProfilerandprotectstheimplantfromdamage.TheProfilerisusedinalatch-type,reductionhandpieceundercopiousamountsofsterileirrigation.Followingremovaloftheexcessboneandsofttissue,unscrewtheCoverScrewfromtheimplantandseatthechosenprostheticcomponent.

DonotusetheBoneProfilerwithouttheCoverScrewinplacetoprotecttheimplantbodyandprostheticplatform.

BoneProfilersarenotincludedintheExternalSurgicalKit,butmaybepurchasedseparately(seepage9).

•Compatiblewithlatch-type,speed-reducinghandpieces

•850-2,500rpmdrillspeedwithsteadysterileirrigation7

•Color-codedbyspecificimplantbodydiameter

Purpose:Removeandcontourexcessboneandsofttissuefromtheareaoftheprostheticplatform.

ANCILLARYINSTRUMENTS

BoneProfilers

BurTestingGauge

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LAPPENDIX

SurgicalKitCleaning

ExternalSurgicalKits(ref.160-500)areprovidednon-sterileandmustbecleanedandsterilizedbeforethefirstandeachsubsequenteachuse,inaccordancewiththeappropriateInstructionsforUse(ref.L0202P).Removeinstrumentsfromthepackageanddiscardpackingmaterialspriortocleaning/sterilization.Double-checkinstrumentstoensuretheirfunctionalitypriortosurgery.VerifythedimensionalaccuracyofdrillshanksusingaBurTestingGauge(oppositepage).

Cleaningwithhydrogenperoxideorotheroxidizingagentswilldamagethesurfaceofinstruments.

1.DisassembletheSurgicalKitandwashthetrayusingabroadspectrumcleaning/disinfectingagentsuchasHu-FriedyEnzymax®orequivalent.Rinsethetraywithwateranddrythoroughly.

2.Placetheinstrumentsinabeakerofdetergentsolutionandsonicatefor10minutes.Rinsethoroughly.3.Removeanyvisibledebrisfromtheinstrumentswithasoftbristlebrush.Rinsethoroughly.4.Rinseinstrumentswithisopropylalcoholtoremoveanysoapresidueandminerals(importanttohelppreventcorrosion).5.Blotinstrumentswithalint-freetowelandallowthemtoairdrycompletely.6.Returninstrumentstotheappropriatelocationinthesurgicaltray.7.Wrappingthekitinstandardapprovedsterilizationwrap,useoneofthreequalifiedsteamsterilizationcycles: a.PrevacuumSteam:132ºC(270ºF)forfiveminutesminimum. b.GravitySteam:132ºC(270ºF)forthirtyminutesminimum. c.GravitySteam:121ºC(250ºF)forfiftyminutesminimum.8.Dryfor20to50minutesasneeded.

Propertesting,cleaningandcalibrationofsterilizationequipmentmustbedoneatregularintervalstoensurethatunitsareinproperworkingorder.Equipmentoperatingconditionsvaryanditistheresponsibilityofeachdentalofficetoensurethatpropersterilizationtechniqueforinstrumentationisfollowed.

Prior tosurgery,cliniciansmayopt to layout instruments in thesterilefield in theorderofuse, tohelpensurecorrectprogressionthroughthesurgicalsequence.Itisrecommendedtohaveback-upsteriledrillsavailablepriortobeginningasurgicalprocedure.

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StarterDrillRef.122-103Ø2.5mmDepthDrillsRef.122-225,122-12509,122-12512and122-12515WidthIncreasingDrillsRef.122-230,122-232,122-237,122-242,122-247and122-252

Thedesignanddiameter(2.0mm)ofthenewStarterDrillobviatestheneedforØ2.0mmDepthDrillSeries(122-220,122-12009,122-12012and122-12015),andthereforetheyhavebeenremovedfromthedrillingsequence.

BioHorizonsrecommendsagainst intra-operativecomminglingofthepreviousandnewdrilldesigns,asdoingsomayresultinaninaccurateosteotomydepth.However,clinicianjudgmentasrelatedtoanyspecificcaseortheuseofanyinstrumentalwayssupersedesanyrecommendationsmadeinthisoranyotherBioHorizonsliterature.

PreviousandNewDesignDrillsmaybedifferentiatedbycomparisonofthecuttingflutes.Theflutesonthepreviousdesignstopbelowthedepthmarks.NewDesignDrillshavecuttingflutesthatextendthroughtheDepthMarks(seeDiagramA).PleaseconsultyourBioHorizonsProductSupportSpecialistorCustomerCareifyouareuncertainofwhichdesigndrillsyouhave.

In July 2007 BioHorizons introduced a new surgical drill design in the External Surgical Kit (ref. 160-500). The following information applies only to clinicians with earlier External Surgical Kits which were provided with the previous design drills. It is important that clinicians be able to distinguish between previous and new drill designs.Affected drills include:

Previous design

New design

CuttingFlutesextendthroughtheDepthMarks

CuttingFlutesendbelowthe

DepthMarks

DiagramA.Differentiatingbetweendrilldesigns

APPENDIX

ImportantInformationRegardingPreviousExternalSurgicalKits(ref.160-500)

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1.HumanHistologicEvidenceofaConnectiveTissueAttachmenttoaDentalImplant.MNevins,MLNevins,MCamelo,JLBoyesen,DMKim.International Journal of Periodontics & Restorative Dentistry. Vol. 28, No. 2, 2008

2.AProspectiveMulticenterClinicalInvestigationofaBone-QualityBasedImplantSystem.KlineR,HoarJ,BeckG,HazenR,ResnikRandCrawfordE.Implant Dentistry, 224-234, Vol. 11 No. 3, 2002

3.Five-YearProspectiveStudyofImmediate/EarlyLoadingofFixedProsthesesinCompletelyEdentulousJawswithaBoneQuality-BasedImplantSystem.MischCEandDegidiM.Clinical Implant Dentistry and Related Research, 17-27, Vol. 5 No. 1, 2003

4.ImmediateFunctionalandNon-FunctionalLoadingofDentalImplants:a2-to60-MonthFollow-UpStudyof646TitaniumImplants.DegidiMandPiattelliA. J Periodontology 2003;74:225-241

5.Non-FunctionalImmediateTeethinPartiallyEdentulousPatients:APilotStudyof10ConsecutiveCasesUsingtheMaestroDentalImplantSystem.MischCE.Compendium Special Issue, 25-36, 1998

6.EffectsofImplantThreadGeometryonPercentageofOsseointegrationandResistancetoReverseTorqueintheTibiaofRabbits.SteigengaJ,Al-ShammariK,MischC,NocitiFandWangH-L,J Periodontology 2004;75:1233-1241

7.DensityofBone:EffectonSurgicalApproachandHealing.CEMisch.Contemporary Implant Dentistry. Second Edition. Mosby: St. Louis, 1999. 371-384.

8.TheInfluenceof0.12%ChlorhexidineDigluconateRinsesontheIncidenceofInfectiousComplicationsandImplantSuccess.LambertP,MorrisHandShigeruO.J Oral Maxillofac Surg, 1997, 55:25-30 Suppl 5

9.Heatproductionby3implantdrillsystemsafterrepeateddrillingandsterilization.ChaconGE,BowerDL,LarsenPE,McGlumphyEA,BeckFM. J Oral Maxillofac Surg. 2006 Feb;64(2):265-9

10.RootFormSurgeryintheEdentulousMandible:StageIImplantInsertion.CEMisch. Contemporary Implant Dentistry. Second Edition. Mosby: St. Louis, 1999. 347-369.

11. Implantabutmentscrewtorquegeneratedbygeneraldentistsusingahanddriverinalimitedaccessspacesimulatingthemouth.E.Hill,S.PhillipsandL.Breeding. J. of Oral Implantology. 2007 Vol. 33(5):277-279

APPENDIX

References

Aperiodofunloadedhealing isoftenrecommended,dependingon individualpatienthealingratesandinitial implantstability.Eachcasemustbeindependentlyevaluated.Thisunloadedhealingperiodallowsforintegrationbetweentheboneandimplantsurface.

Thepatientmustbeinstructedtofollowapost-surgicalregimenincludingcoldpacksfor24hourspost-implantation.Thepatient’sdietshouldconsistofsoftfoodsandpossiblyliquiddietarysupplements.Pharmacologicaltherapyshouldbeconsideredasthepatient’sconditiondictates.

Ifaremovableprosthesisisusedduringtheinitialhealingphase,itisrecommendedthatasoftlinermaterialbeusedtopreventpressureonthesurgicalsite.Thissoftlinershouldberelievedovertheimplantsite.Thepatientshouldbecheckedperiodicallytomonitorhealingofthesofttissuesandboneusingclinicalandradiographicevaluations.

Ongoinghygienefortheimplantpatientisvital.Hygienerecallappointmentsatthreemonthintervalsaresuggested.Instrumentsdesignedforimplantscaling,suchasImplacare®instrumentsfromHu-Friedy®shouldbeutilized.Thestainlesssteelhandlesmaybefittedwithassortedtipdesignsusedforhygieneonnaturalteeth.TheImplacare®scalerswillnotdamageimplantabutmentsandcontainnoglassorgraphitefillersthatcanscratchtitaniumimplantabutments.

Post-operativeConsiderations

60

Product Support Specialist:

Cell phone:

Fax:

BioHorizons No Exceptions Lifetime Warranty on Implants and Prosthetics:BioHorizonsimplantsandprostheticcomponentscarryaLifetimeWarranty.WewillreplaceanyBioHorizonsimplantorprostheticcomponentifremovalof

thatproductduetofailure(excludingnormalweartooverdentureattachments)isrequiredforanyreason,atanytime.

Warranties on Instruments, Surgical Drills, Taps and Torque Wrenches:BioHorizonswarrantiesinstruments,surgicaldrills,tapsandtorquewrenchesfortheperiodspecifiedforeachin(1)&(2)below.Duringthespecifiedwarranty

periodwewillreplaceorrepairanyproductwithadefectinmaterialorworkmanship.

(1)ThewarrantyonBioHorizonsinstrumentsextendsforaperiodofone(1)yearfromthedateofinitialinvoice.Thisincludesdrivers,

sinusliftcomponents,implantsitedilatorsandotherBioHorizonstoolsusedintheplacementorrestorationofourimplants,withthe

exceptionofsurgicaldrillsandtaps(seebelow).

(2)ThewarrantyonBioHorizonsSurgicalDrillsandTapsextendsforaperiodofninety(90)daysfromthedateofinitialinvoice.Surgical

drillsand tapsshouldbe replacedwhen theyareworn,dull, corrodedor inanywaycompromised.BioHorizons recommends the

replacementofdrillsafter12to20osteotomies.9

Return Policy:Instructionsforinitiatingreturnscanbefoundonthereversesideoftheinvoicethatwasshippedwiththeproduct.PleasecontactCustomerCareifyouneed

acopyoftheinstructionsorifyouhaveadditionalquestionsorrequests.

BioHorizons USA Customer Care/Servicio al Cliente: ��-��6-�� / �05-967-7��0

BioHorizons Canada Customer Care/Service à la Clientèle: �66-�6�-�� / 905-9��-�700

BioHorizons Spain Atención al Cliente: +�� 9� 7�� 0 ��

BioHorizons Germany Kunden Service: +�9 766�-9099�9-0

BioHorizons UK Customer Care: +�� 700 6�0 550

BioHorizons Australia Customer Service: +6� � ��99 �5�0

BioHorizons Chile Atención al Cliente: +56 � �6� 95�9

BioHorizons Mexico Servicio al Cliente: +5� 55 55�5 ��97

ORDERINGANDWARRANTYINFORMATIONA

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Disclaimer of Liability This literatureservesasreferenceforBioHorizonsExternal implants,prostheticsandinstrumentation. It isnot intendedtodescribethemethodsor

proceduresfordiagnosis,treatmentplanning,orplacementofimplants;nordoesitreplaceclinicaltrainingoraclinician’sbestjudgmentregardingthe

needsofeachpatient.BioHorizonsstronglyrecommendscompletionofpostgraduatedentalimplanteducationandstrictadherencetotheInstructions

forUse(IFU)thataccompanyourproducts.

Treatmentplanningandclinicalapplicationofourproductsaretheresponsibilityofeachindividualclinician.BioHorizonsisnotresponsibleforincidental

orconsequentialdamagesorliabilityrelatingtouseofourproductsaloneorincombinationwithotherproducts,otherthanreplacementorrepairunder

ourwarranties.

BioHorizons dental implants may only be used in conjunction with the associated original components and instruments according to BioHorizons

InstructionsforUse.Useofanynon-BioHorizonsproductsinconjunctionwithBioHorizonsimplantsvoidsanywarrantyorotherobligation,expressed

orimplied,ofBioHorizons.

Validity BioHorizonscontinuallystrivestoimproveitsproductsandthereforereservestherighttoimprove,modify,changespecificationsordiscontinueproducts

atanytime.Uponitsrelease,thisliteraturesupersedesallpreviouslypublishedversions.

Availability Notallproductsshownordescribedinthisliteratureareavailableinallcountries.

Symbol descriptions for product labeling

Reference/partnumber

Sterilebygammairradiation

Non-sterile

Caution:Federal(USA)lawrestrictsthesedevicesby,orontheorderof,adentistorphysician.

Singleuseonly

RefertoInstructionsforUse

Usebeforeexpirationdate(YYYY-MM)

BioHorizonsproductscarrytheCEmarkandfulfilltherequirementsoftheMedicalDevicesDirective93/42/EEC

REF

Lot/batchnumberLOT

RxOnly

NON-STERILE

RSTERILE

Manufacturedate(YYYY-MM)

Implant diameter : surface treatment

Ø3.5mmImplant:RBT

Ø4.0mmImplant:RBT/HA

Ø5.0mmImplant:RBT/HA

Ø6.0mmImplant:RBT/HAØ6.0

Ø4.0

Ø5.0

Ø3.5

Ø4.0

Ø5.0

Ø6.0

ICONLEGENDA

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w w w . b i o h o r i z o n s . c o m

BioHorizonsproductsareclearedforsaleintheEuropeanUnionundertheEUMedicalDeviceDirective93/42/EEC.WeareproudtoberegisteredtoISO

13485:2003,theinternationalqualitymanagementsystemstandardformedicaldevices,whichsupportsandmaintainsourproductlicenceswithHealthCanadaand

inothermarketsaroundtheglobe.

©2008BioHorizonsImplantSystems,Inc.AllRightsReserved.L0129REVCMAY2008

BioHorizons Canada21AmberStreet,Unit#6

Markham,OntarioL3R4Z3

Customer Care / Service à la Clientèle: �66-�6�-�� or / ou 905-9��-�700

BioHorizons SpainSerranoAnguita,10

28004Madrid,España

Atención al Cliente: +�� 9� 7�� 0 ��

BioHorizons GermanyMarktplatz3

79199Kirchzarten

Kunden Service:+�9 766�-9099�9-0

BioHorizons ChileCerroColorado5030,Officina513

LasCondesSantiago,Chile

Atención al Cliente: +56 � �6� 95�9

BioHorizons MexicoKelvin8Dept.303

Col.AnzuresC.P.11590,Mexico,D.F.

Servicio al Cliente:+5� 55 55�5 ��97

BioHorizons Australia 25-33AllenStreet

WaterlooNSW2012

Customer Service: +6� � ��99 �5�0

BioHorizons UK180DukesRide

Crowthorne,BerkshireRG456DS

Customer Care:+�� 700 6�0 550

BioHorizons USA2300RiverchaseCenterBirmingham,AL35244

Customer Care / Servicio al Cliente: ��-��6-�� or �05-967-7��0

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