product overview duraplant - - zl-microdent.com · duraplant implants and drilling tools Ø 2,9 mm...

Precision since 1968

PRODUCT OVERVIEW

DURAPLANT

CONTENTS

2

Principles Page 3

Screw implants Ø 2.9 mm Page 4





Bone spiders Page 9

Bone profilers Page 9

Sulcus formers Page 10

Pick-up impression Page 10

Tiversa customizable Ø 4.1 mm + Ø 5.1 mm Page 11

Tiversa customizable Ø 3.6 mm + Ø 7.8 mm Page 12

Abutments for direct casting Page 14

Reseating impression Page 14

Tiversa rigid Ø 4.1 mm Page 15

Tiversa ball abutments Page 18

Gold caps + Unor bars Page 16

Tiversa rigid Ø 5.1 mm Page 16

Tiversa magnet abutments Page 19

Locator abutments 0

Instrument trays surgery + prosthetics Page 21

X-ray template Page 24

Tectusil silicone sealant Page 25

Durobond Page 25

DURAPLAnT instructions for use Page 28

Recall Page 27

Laboratory accessories Page 26

ZiVersa Zirkon abutments Ø 3,6 mm + Ø 4,1 mm + Ø 5,1 mm Seite 13

PRInCIPLESDental implant treatment is a modern form of dentistry based on biomaterial research. It en-compasses all sub-disciplines in dentistry and incorporates their basic principles.

Though implant treatment is always indicated from the prosthetic point of view, the other branches of dentistry, general medicine and psychiatry may present contraindications.

A compromise always has to be made between the prosthetic ideal, technical limitations and practical options for oral surgery when planning the implant sites as well as when actually placing the implants during surgery. normally this com-promise has to be made intraoperatively

The long-term success of any implant is based on accurately establishing the indication, selecting a suitable implant system for that indication, precise preimplant planning and oral surgery, integrating the prosthetic superstructure in the overall concept for rehabilitating the orofacial system and strict adherence to recall appointments for periodontal examination.

GEnERAL PRInCIPLES FOR IMPLAnT InDICA-TIOn The long-term function of any type of implant basically depends on a stable balance between the effects of the implant on the organism and the potential of that organism to compensate for these effects.

Any therapeutic effect is always accompanied by side effects. Anyone involved in developing implants, as well as any dentist placing implants, is confronted by this fundamental problem.

The aim of our research was to increase the the-rapeutic scope and effectiveness of the system while reducing side effects to a minimum.

Even with an optimized implant system, the procedure used must still follow the principles of dental implantology.

Basically it should be taken into consideration that an implant is a synthetic product an implant-borne restoration requires surgery.

As an implant is a synthetic product, it is not an active component in an evolved feedback control system. Consequently, it is in a much more un-stable state of equilibrium than a tooth. An implant therefore has to be monitored much more closely than a tooth and in planning an implant-borne re-storation the dentist must include adequate safety precautions. Otherwise, even minor noxae could affect the unstable equilibrium of the implant. The indication for implant treatment should be carefully considered and strictly defi ned.

SYSTEM PARAMETERS

1. Vertical space required for crowns:> 5.50 mm

2. Vertical space required bar restorations:> 7.00 mm

3. Max. angle between the implant axis and superstructure axis:- 20° - + 20°

4. Implant lengths: 9 mm12 mm15 mm(Special lengths on request; maintain a safe gap!)

5. Implant diameters:Ø 2,90 mmØ 3,20 mmØ 3,50 mmØ 3,80 mmØ 4,10 mm(Maintain bone wall thickness!)

6. Distance between implants with partial dentures(Splinted crowns)(Special abutment for lower anteriors)> 4.2 mm

7. Distance between implants with bar restora-tions> 9 mm< 20 mm

note:

Our medical and technical safety advisors constantly check information on our products and their application. The user should, however, check our product information and recommenda-tions to ensure that the product is suitable for the intended use. If we make any modifi cations to products or their application in the course of technical or medical development, we reserve the right to supply the modifi ed product. We offer expert advice as a free customer service without liability. Claims for compensation are restricted to claims made under guarantee and to the contractual terms of our general conditions of sale and delivery.

COnTRAInDICATIOnSIf the patient has a known general or specifi c me-dical condition or even psychosocial problems that would have a negative effect, i.e. compensation mechanisms are clearly limited or noxae will be excessive, implant treatment cannot be carried out without accepting considerable risks. Based on these principles, there are a number of conditions or illnesses that contraindicate implantation.The following are contraindications:

1. Surgery does not seem justifi able.

2. The patient has a condition or illness that may affect normal wound healing.

3. The patient has a condition or illness that affects normal functioning of the immune system.

4. The patient has a condition or illness that pre-cludes normal bone reactivity.

5. The patient has a condition or illness that nega-tively affects the relation between the load transfer-ring implant surface and applied stresses.

6. The patient has a condition or illness that increases bacterial or mechanical loading of the abutment emergence profi le beyond its potential for compensation.

7. The patient has a condition or illness that makes the patient unwilling or unable to recognise the particular advantages and special hygiene require-ments of an implant-borne restoration.More detailed information can be found in the literature.

We reserve the right to make technical changes. no part of this publication may be reprodu-ced without our prior permission in writing.

PRINCIPLESDURAPLANT

3

Copyright © 2009 byZL-MICRODEnT-ATTACHMEnT GMBH & CO. KGD-58335 Breckerfeld

Registered Trademarks of ZL Microdent:Bone-spider®,Bone-up®, DURAPLAnT®,DUROBOnD®, MICRODEnT® ,Tectu-Sil®,TICER®, TILABOR®, TIMEDUR®,TIVERSA®,Unor®, ZL MICRODEnT®.

Registered Trademarks ofZest Anchor Ltd.: Locator®

10101 Pilot drill

10102 Measuring pin

10100 Measuring pin angled 20°

10105 Thread tap

10104 Countersink

10103 Gun drill

11115 Implant length 15 mm



IMPLANTS AND DRILLING TOOLS Ø 2,9 mm DURAPLANT

4

DURAPLAnT-implants are packed sterile and supplied with a healing cap and integrated insertion instrument.

A cortical/spongiosa bone thread, based on that used in major surgery and adapted to the special require-ments of oral surgery, ensures optimal primary stability following implant placement and excellent force-load transmission in the bone after a pro-sthetic restoration has been fitted.

The TIMEDUR® drilling tools listed here are required for placement of the implant. To avoid contamination with foreign metals, the tools should only come into contact with titanium instruments and be cleaned with glass-fibre brushes. Drilling tools can be used several times (maximum 10 x).

Information on implant placement wit-hout alteration to the bone site is inclu-ded in the ZL Duraplant implant system instructions for use on Pages 8 - 11.

All implants are supplied with a healing cap.




10201 Pilot drill

10202 Measuring pin


10205 Thread tap

10204 Countersink

10203 Gun drill


5






10301 Pilot drill

10302 Measuring pin


10305 Thread tap

10304 Countersink

10303 Gun drill





6









10401 Pilot drill

10402 Measuring pin


10405 Thread tap

10404 Countersink

10403 Gun drill


7



The TIMEDUR® drilling tools listed here are required for placement of the implant. To avoid contamination with foreign metals, the tools should only come into contact with titanium instruments and be cleaned with glass-fi bre brushes. Drilling tools can be used several times (maximum 10 x).






10501 Pilot drill

10502 Measuring pin


10505 Thread tap

10504 Countersink

10503 Gun drill


8


A cortical/spongiosa bone thread, based on that used in major surgery and adapted to the special require-ments of oral surgery, ensures optimal primary stability following implant placement and excellent force-load transmission in the bone after a pro-sthetic restoration has been fitted..




In many cases there is not adequate bone availability in the optimum region for implant insertion with regard to the prosthetic restoration. This may require various augmentation procedures:• augmentation using membrane techniques• bone splitting• free bone reimplantation at the site/ free bone graft. In these cases the Bone Spider is placed on the implant instead of the standard healing cap. Because its legs can be easily adapted and shortened, it can:• stabilize fragile bone lamellae following bone splitting• form augmentation cavities, which are then covered with a membrane• retain free bone grafts at the implant site.

Information on implant placement with bone site alteration and bone spiders is included in the ZL Duraplant implant system instructions for use on Pages 12 + 13.

10520 Bone spider three-legged 10530 Bone spider six-legged

10567 Bone profi ler Ø 5,1 mm short

10466 Bone profi ler Ø 4,1 mm long

10467 Bone profi ler Ø 4,1 mm short

10432 Guide pin

10566 Bone profi ler Ø 5,1 mm long

Information on the technique with bone profi lers is included in the ZL Duraplant implant system instructions for use on Pages 15 - 17.

BONE SPIDERSDURAPLANT

BONE PROFILERS BONE PROFILERS BONE PROFILERS

9

After the standard healing period the implant is exposed and the healing cap is replaced with a sulcus former. This step prepares the implant for prosthetic use.

In aesthetically critical areas the basis for the gingival aesthetics is also completed at this stage. The peri-implant mucosa is contoured to suit the aesthetic and functional requirements. It is possible to place a sulcus former immediately with the same diameter as the subsequent abutment or begin with a 3.1 mm diameter sulcus former and expand the mucosa to 4.1 mm or 5.1 mm in weekly cycles (sequential mucosa expansion; GRAF and BLUME 1999). This conditions the tissue and induces an increase in volume, which is recommended in aesthetically critical regions with implant-borne crowns, splinted crowns and bridges.

10702 Sulcus former Ø 3,1 mm 10703 Sulcus former Ø 4,1 mm 10705 Sulcus former Ø 5,1 mm

Information on fi tting sulcus formers is included in the ZL Duraplant implant system instructions for use on Pages 15 – 18.

Information on the technique with pick-up impression posts is included in the ZL Duraplant implant system instructions for use on Pages 25 - 26.

10146 Pick-up post Ø 4.1 mm short

10148 Pick-up post Ø 5.1 mm short

10147 Pick-up post Ø 4.1 mm long

10145 Implant analogue

10149 Pick-up post Ø 5.1 mm long

SULCUS FORMERSDURAPLANT

PICK-UP IMPRESSION PICK-UP IMPRESSION PICK-UP IMPRESSION

10

PICK - UP ABUTMENTS DURAPLANT

11

Information on the technique with customizable abutments is included in the ZL Duraplant implant system instructions for use on Pages 27 - 29.

Information on the technique with customizable abutments is included in the ZL Duraplant implant system instructions for use on Pages 27 - 29

1,1 mm

2,1 mm

3,1 mm

10° 15° 20°0°

11461 11462 1146411463

11445 11446 1144811447

11441 11443 1144411442

Tiversa customizable Ø 4,1 mm Tiversa customizable Ø 4,1 mm Tiversa customizable Ø 4,1 mm


1156311561 1156411562

1155611555 1155811557

1155211551 1155411553

0° 20°15°10°

1,1 mm

2,1 mm

3,1 mm


1,1 mm

2,1 mm

3,1 mm

0°

11362

11361

11360


12

Information on the technique with customizable abutments is included in the ZL Duraplant implant system instructions for use on Pages 27 - 29.

Information on the technique with customizable abutments is included in the ZL Duraplant implant system instructions for use on Pages 27 - 29

11440

0°


10719 Transversal screw for insertion key

10709 Transversal screw

10435 Centre screw

Screws Tiversa customizable Screws Screws

1,1 mm

13


11371 Abutment incl. screw, height 1,1 mm / 0°

ZiVersa Ø 3,6 mm ZiVersa Ø 3,6 mm ZiVersa Ø 3,6 mm

11471

11472

11474

Abutment incl. screw, height 1,1 mm / 0°




11571

11572

11574





11535 Centre screw ZiVersa abutments

ZiVersa Schraube ZiVersa Schraube ZiVersa Schraube

10228 Implant analogue Ø 5.1 mm


10144 Impression cap Ø 5.1 mm long

10140 Impression cap Ø 4.1 mm short

10143 Impression cap Ø 4.1 mm long

10141 Impression cap Ø 5.1 mm short


Reseating impression Reseating impression Reseating impression

PICK - UP + RESEATING ABUTMENTS

Information on the technique with reseating impression caps is included in the ZL Duraplant implant system instructions for use on Pages 21 - 22.

Direct casting abutm. Ø 4,1+5,1mm

11853 Abutment Ø 4,1 with rotational security

11851 Abutment Ø 5,1 without rotational security

11850 Abutment Ø 4,1 without rotational security

11854 Abutment Ø 5,1 with rotational security

14

15

DURAPLANT PICK - UP + RESEATING ABUTMENTS

11743 Plastic cap + occlusal screw

11742 Plastic crown + transversal screw

11123 Abutment Ø 4.1 mm / H 3.1 mm





Tiversa rigid Ø 4.1 mm Tiversa rigid Ø 4.1 mm Tiversa rigid Ø 4.1 mm

Temporaries Tiversa rigid Ø 4.1mm Temporaries Tiversa rigid Ø 4.1mm Temporaries Tiversa rigid Ø 4.1mm

Burnout caps Tiversa rigid Ø 4.1 mm Burnout caps Tiversa rigid Ø 4.1 mm Burnout caps Tiversa rigid Ø 4.1 mm

11117 Titanium crown with rotational security

11116 Titanium crown without rotational security

10747 Occlusal screw long


10719 Occlusal screw

Titanium crowns Tiversa rigid Ø 4.1 mm

Screws Tiversa rigid Ø 4.1 mm Screws Tiversa rigid Ø 4.1 mm Screws Tiversa rigid Ø 4.1 mm

Information on the technique with the Tiversa rigid abutment range is included in the ZL Duraplant implant system instructions for use on Pages 20 - 24.





Tiversa rigid Ø 5.1 mm Tiversa rigid Ø 5.1 mm Tiversa rigid Ø 5.1 mm



Temporaries Tiversa rigid Ø 5.1mm Temporaries Tiversa rigid Ø 5.1mm Temporaries Tiversa rigid Ø 5.1mm



Burnout caps Tiversa rigid Ø 5,1 mm Burnout caps Tiversa rigid Ø 5,1 mm Burnout caps Tiversa rigid Ø 5,1 mm

11139 Titanium crown with rotational security

11134 Titanium crown without rotational security

Titanium crowns Tiversa rigid Ø 5,1 mm

10747 Occlusal screw long



Screws Tiversa rigid Ø 5.1 mm Screws Tiversa rigid Ø 5.1 mm Screws Tiversa rigid Ø 5.1 mm

Information on the technique with the Tiversa rigid abutment range is included in the ZL Duraplant implant system instructions for use on Pages 20 - 24.

16


10734 Gold cap


11734 Gold caps + occlusal screw

Gold caps Tiversa rigid Ø 4.1 mm

10738 Unor® gold bar secondary

10737 Unor® gold bar primary

11737 Unor® gold bar complete

10729 Bar rider gold

Unor® gold bars Unor Unor

691

675

671

677

681 Bar, oval, 50 mm M

665 Bar rider, parallel, 50 mm M

661 Bar, parallel, 50 mm M

664 Bar rider, oval, 50 mm M

Bar rider, oval, 50 mm n

Bar, parallel, 50 mm n

Bar rider, parallel, 50 mm n

Bar, oval, 50 mm n

Bar attachments and resilient bars n+M

17

Information on the technique with Ti-versa rigid gold caps and UnOR bars is included in the ZL Duraplant implant system instructions for use on Pages 41- 45.


10716 Ball abutment / H 3.1 mm



11716 Ball abutment complete / H 3.1 mm



Ball abutment complete includes a matrix

10745 Ball abutment activation insert

10717 Ball abutment matrix complete

10751 Implant analogue ball abutment

10746 Ball abutment activation screw

Tiversa ball abutments

Components Tiversa ball abutments

Replacement Tiversa ball abutments

Information on the technique with the Tiversa ball abutment range is included in the ZL Duraplant implant system instructions for use on Pages 30 - 33.

18


19

Information on the technique with the Tiversa magnet abutment range is inclu-ded in the ZL Duraplant implant system instructions for use on Pages 34- 35.

10916 X magnet implant analogue

10915 X magnet impression post

10914 Positioning sleeve No. 2, fl at

10917 X magnet applicator

10913 Positioning sleeve no.1, raised

10910 Magnet X insert, H 3.75 mm

10911 Magnet X insert, H 5.25 mm

10912 X denture titanium magnet

Tiversa magnet abutments


10925 Locator implant analogue

10924 Locator impression cap

10921 Locator abutment / H 2.1 mm

10922 Locator abutment / H 3,1 mm

10919 Locator matrix set (0°-10°)

10920 Locator abutment / H 1.1 mm

10935 Locator angle measuring pin

10934 Locator insertion instrument

10933 Locator laboratory instrument

10937 Locator friction inserts (10°-20°)

10936 Locator angle gauge

Tiversa Locator abutments Tiversa Locator abutments Tiversa Locator abutments

Friction insert biue 680 g = 6,7 n

Friction insert green 1815 g = 17,8 n

Friction insert pink 1360 g = 13,4 n

Friction insert clear 2265 g = 22,3 n

Friction insert red 435 g = 4,5 n

Tiversa Locator removal forces Tiversa Locator removal forces Tiversa Locator removal forces

20

DURAPLANT TRAY 1 SURGERY + PROSTHETICS

10757 Screwdriver S3L

10836 College tweezers titanium

10780 Torque ratchet 20 ncm

10810 Socket wrench

10762 Extension V2

10765 Ring key

10800 Ratchet

10127 Screwdriver S2M


10761 Extension V1

10125 Screwdriver S2S

10129 Screwdriver S1S


10329 Screwdriver S1M

10050 Steribox tray no. 1

Order no. 11050

21

DURAPLANT TRAY 2 DRILLING TOOLS

10429 Handpiece drive for thread tap

10760 Drill extension x 1

Additional instruments, not contained in the tray

10202 Measuring pin for Ø 3.2 mm x 3

10302 Measuring pin for Ø 3.5 mm x 3

10200 Measuring pin 20° for Ø 3.2 mm x 110102 Measuring pin for Ø 2.9 mm x 3

10300 Measuring pin 20° for Ø 3.5 mm x 1

10100 Measuring pin 20° for Ø 2.9 mm x 1

10101 Pilot drill for Ø 2.9 mm x 210201 Pilot drill for Ø 3.2 mm x 210301 Pilot drill for Ø 3.5 mm x 2


10104 Countersink for Ø 2.9 mm x 210204 Countersink for Ø 3.2 mm x 210304 Countersink for Ø 3.5 mm x 2

10103 Gun drill for Ø 2.9 mm x 210203 Gun drill for Ø 3.2 mm x 210303 Gun drill for Ø 3.5 mm x 2

10105 Thread tap for Ø 2.9 mm x 210205 Thread tap for Ø 3.2 mm x 210305 Thread tap for Ø 3.5 mm x 2

Order no. 11020

22

DURAPLANT TRAY 4 DRILLING TOOLS

10429 Handpiece drive for thread tap

10760 Drill extension x 1

Additional instruments, not contained in the tray

10502 Measuring pin for Ø 4.1 mm x 310500 Measuring pin 20° for Ø 4.1 mm x 110402 Measuring pin for Ø 3.8 mm x 310400 Measuring pin 20° for Ø 3.8 mm x 1

10401 Pilot drill for Ø 3.8 mm x 210501 Pilot drill for Ø 4.1 mm x 2


10404 Countersink for Ø 3.8 mm x 210504 Countersink for Ø 4.1 mm x 2

10403 Gun drill for Ø 3.8 mm x 210503 Gun drill for Ø 4.1 mm x 2

10405 Thread tap for Ø 3.8 mm x 210505 Thread tap for Ø 4.1 mm x 2

Order no. 11040

23

DURAPLANT X-RAY TEMPLATE

Surgical planning is based on the fi n-dings of the preimplant diagnosis and the treatment objectives. It takes into account surgical, prosthetic and labo-ratory aspects of the planned treatment and is the product of close cooperation between the dental technician and dentist.

The result of this is a surgical stent. This, however, contains a number of inherent residual errors. This is why the intra-operative implant position determined with the stent must always be checked for accuracy using appropriate measu-res, e.g. calliper gauge, measuring pin (GRAF and HIRSCH 2000).

Information on surgical planning and fabricating the stent is included in the ZL Duraplant implant system in-structions for use on Pages 4 - 7.

24

DUROBOnD®

1 Mixing pad

1 x 2.5g each of base and catalyst paste

1600 DUROBOnD®

1 Mixing spatula

DURAPLANT TECTUSIL SILICONE SEALANT

DURAPLANT DUROBOND ADHESIVE

25

DUROBOnD® is a dual-curing bonding composite for passive retention of cast implant superstructures on prefabrica-ted titanium primary crowns.

Tectu®Sil is a two-component additi-on-cured silicone for fi lling and sealing cavities between implant abutments and the superstructure. It ensures that there is no bacterial colonization and is also an excellent material for securing screws in position.

A standard cartridge dispenser is re-quired for application.

15 Intraoral tips

15 Mixing tips

10550 Tectu®Sil silicone sealant 50 ml

Tectu®Sil Tectu Tectu

DURAPLANT ACCESSORIES + INSTRUMENTS

10767 Activator (anchor system)

476 Thread tap M 1.6 x 0.2 mm

10145 Implant analogue pick-up

10110 Twist drill (for 10107, 10108)



10107 X-ray reference pin

10108 Drill guide sleeve (pilot drill Ø 2.9 mm)

10762 Extension V2

10758 Space maintainer for customized impression trays (pick-up)

10757 Screwdriver S3L (customizable abutments)

10218 Reseating instrument (Tiversa rigid Ø 5.1 mm)


10229 Screwdriver S1L (pick-up)

10217 Reseating instrument (Tiversa rigid Ø 4.1 mm

10751 Implant analogue (anchor system)

10769 Paralleling mandrel (telescope bars)

26

During the standard healing period there is up to three times more bone coverage (assuming normal bone conditions) on a Ticerim-plant surface than on a titanium implant surface (KnÖFLER and GRAF 1988). There is also further bone coverage after this period.

Functional loading, which only occurs after implant recovery and is transmitted to the implant via the sulcus former, creates forces that further adapt the peri-implant bone. This results in additional (load-induced) remodelling of the bone with increased bone coverage.

In the fi rst three months after fi tting a superstructure with greater functional loading, this load-induced bone remodelling process intensifi es and should therefore be monitored.

While monitoring the remodelling process, the static and dynamic occlusion can be checked for any possible problems.

Repeated loosening of the screws at this stage clearly indicates stresses between the superstructure and implants. According to WEBER, BENZING and GEISS-GERSTORFER (1988) loading on the implant/bone interface resulting from loose-fi tting superstruc-tures is possibly much greater than masticatory loading, even with superstructures that were clinically satisfactory at try-in.

Signs of changes in the peri-implant conditions become apparent at a later stage.

At least once a year after the fi rst year

2 weeks after fi tting

1 week after fi tting

4 weeks after fi tting

12 months after fi tting

2 months after fi tting

6 months afterfi tting

Fitting the super-structure

Recall Schedule

DURAPLANT RECALL

27

Manufacturer: ZL-MICRODEnT-ATTACHMEnT GMBH & Co. KGSchützenstraße 6-8, 58339 BreckerfeldTel.: 02338-8010 Fax: 02338-80140

1. General InformationDURAPLAnT implants should only be used by appropriately qualifi ed dentists and doctors and superstructures should only be fabricated by trained dentists and dental technicians. The following instructions for use are not suffi ciently comprehensive to allow immediate use of the implant system. We strongly recommend that an experienced colleague provides instruction and supervision on the use of the implant system.

2. Description of DURAPLAnT implants Screw implants fabricated from TIMEDUR® cold-hardened pure titanium with a TICER® surface in diameters of 2.9, 3.2, 3.5, 3.8 and 4.1 mm and in lengths of 9, 12 and 15 mm. As DURAPLAnT implants form part of a whole concept, only original components and instruments should be used in accordance with the instructions and recommen-dations of the manufacturer. The manufacturer accepts no responsibility if components from other manufacturers are used.

2.1 Materials Implants: TIMEDUR® pure titanium TICER® surface Healing caps and secondary units: TIMEDUR® pure titanium Instrumentarium: TIMEDUR® pure titanium, stainless steel, all components can be sterilized in an autoclave Prosthetic primary units: TIMEDUR® pure titanium Prosthetic secondary units: TIMEDUR® pure titanium, Au-Pt alloy or POM (plastic)

3. IndicationsDURAPLAnT implants cover all indications for endosteal implants in the upper and lower jaw with the exception of immediate loading implants. The implants can therefore be used in the rehabilitation of an edentulous jaw or a partially edentulous jaw. Crowns, bridges and dentures can be used as prosthetic restorations.

3.1. ContraindicationsConditions or illnesses that make surgery seem unjustifi able affect normal wound healing

cause problems with normal functioning of the immune system preclude normal reactivity of the bone.

nOTE: Periodontal disease should be controlled by hygiene and/or surgical measures before implant treatment. Poor oral hygiene and lack of cooperation by the patient are further contra-indications.

The implants must not be contaminated in any way and should be kept in the sterile pack until immediately before insertion. If handling the implant is unavoidable, the titanium tweezers supplied should always be used.

nOTE: The ratchet should be dismantled immedi-ately after use and the individual units thoroughly cleaned and disinfected.

8. Packaging and sterilityThe DURAPLAnT implant packaging compri-ses: non-sterile storage packaging with instructions for use and separate adhesive labels for the patient ID card and patient fi le

secondary packaging as a germ barrier (glass bottle with screw seal) sterile primary packaging (glass bottle with silicone seal and placement aid for the sterile implant)

A DURAPLAnT implant that has been used, is non-sterile or contaminated, should never be implanted. Important: If the original packaging is damaged, the implant cannot be returned to the manufacturer.

9. SterilizationDURAPLAnT implants are sterilized by gamma radiation.

10. ResterilizationDURAPLAnT implants should never be re-sterilized. The manufacturer accepts no re-sponsibility if the implant has been resterilized.

11. StorageDURAPLAnT implants should be stored in their original packaging in a dry place at normal room temperature. The implants should not be used after the sterilization expiry date.

12. Traceability and documentation Implants can be traced using the order and batch numbers. It is possible to trace the implants from the patient to the manufacturer by means of the adhesive labels on the patient ID card and patient fi le. For forensic reasons the manufacturer recom-mends full clinical, radiological, photographic and statistical documentation.

13. Sale of DURAPLAnT implantsDURAPLAnT implants are for sale exclusively to doctors and dentists. We strongly recommend attending a manufacturer’s training course.

4. Side effects and interactionsExtreme physical loading should be avoided postoperatively. Titanium implants have no known side effects.Possible complications: damage to anatomical structures (permanent anaesthesia caused by damage to the inferior alveolar nerve, perforation of the nasal cavity or maxillary sinus) chronic pain related to the implant

fractures: bone fracture, implant or instrument fracture, fracture of the restoration periimplant infl ammation

nOTE: If unexpected pain or complications occur, the doctor or dentist responsible for treatment should be consulted immediately. It is a known fact that implants sometimes do not heal and fail without any apparent cause.

5. Preoperative planningGeneral medical examination; full clinical and radiological dental examination; informing the patient about indications, contraindications and success rates; informing the patient about the need for regular checkups, including setting up an oral hygiene regime, involving sanitation by periodontal surgery if necessary; establishing an overall preoperative and prosthetic plan in consultation with the dental technician.

6. Surgical techniqueDURAPLAnT training covers instruction in the surgical technique used with the system. A skilful operating technique in the hard and soft tissue is essential to create optimum conditions for implant healing.

nOTE: The drill should be 1 mm longer than the insertion depth of the implants.

The following measures are necessary to pre-vent any thermal preparation trauma: low motor speed of 500 to 800 rpm use of sharp drills use of DURAPLAnT drills in ascending order of diameter size internal and/or external cooling of the drills with sterilized sodium chloride solution implants with a diameter of 3.8 mm or 4.1 mm should never be used as self-tapping implants

The standard healing period is 3 months in the lower jaw and 6 months in the upper jaw. Implants should not be loaded prosthetically until after these healing periods.

7. General handlingAll instruments should be thoroughly cleaned, disinfected and sterilized before use. General rules of hygiene for surgical operations should be followed before each operation to reduce germs to an absolute minimum.

DURAPLANT INSTRUCTIONS FOR USE

28

DURAPLANT FOR YOUR NOTES

29

30

FAX-ORDER ++ 49 2338 801 40

Adress:

ZL-Microdent Attachment GmbH & Co. KGSchützentrasse 6 - 8D 58335 Breckerfeld

( ++ 49 2338 801 0 )


Order-nr. Pieces Order-nr. Pieces Order-nr. PiecesOrder-nr. Pieces

ZL MICRODEnTAttachment GmbH & Co. KG Postfach 360D 58335 Breckerfeld

Tel. ++49 2338 801-0 Fax. ++49 2338 801-40 [email protected] www.zl-microdent.de

Dr.N

r.: P

R. D

URA

. EN

. 01

/17


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product overview duraplant - - zl-microdent.com · duraplant implants and drilling tools Ø 2,9 mm...

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