food and drug administration › cdrh510k › k131799.pdf15. biocompatibility 16. software 17....
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(b)(4) Trade Secret Process- Draft Label
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(b)(4) Trade Secret Process - Product Specs
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(b)(4) Trade Secret Process
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Traditional 510K Table of Contents
QuicKnit™
1. Medical Device User Fee Cover Sheet (Form FDA 3601)
2. CDRH Premarket Review Submission Cover Sheet
3. 510(k) Cover Letter
4. Indications for Use Statement
5. 510(k) Summary or 510(k) Statement
6. Truthful and Accuracy Statement
7. Class III Summary and Certification
8. Financial Certification or Disclosure Statement
9. Declarations of Conformity and Summary Reports
10. Executive Summary
11. Device Description
12. Substantial Equivalence Discussion
13. Proposed Labeling
14. Sterilization and Shelf Life
15. Biocompatibility
16. Software
17. Electromagnetic Compatibility and Electrical Safety
18. Performance Testing – Bench
19. Performance Testing – Animal
20. Performance Testing – Clinical
21. Other
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Indications for Use
510(k) Number (if known):
Device Name: Quicknit Cord
Indications for Use: Quicknit Cord is unimpregnated cord for the temporary retraction of the gingival margin.
The gigival retraction cord is placed in the sulcus (between the gum tissue and your tooth structure) to
displace the gum tissue for a small period of time in dental procedures.
This product does not require a prescription for use. Professional use is recommended Prescription Use ___X___ AND/OR Over-The-Counter Use _______ (21 CFR Part 801 Subpart D) (21 CFR Part 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE) Page 1 of __1__
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There were no prior submissions for same subject device (Quicknit Cord).
Peggy Gober
Quality Manager
Microcopy
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Device Description
Quicknit is a dental retraction cord product made to be used specifically to retract gingiva tissue
and prevent fluid from saturating the sulcus during a crown preparation. Quicknit retraction
cord is made of 100% cotton that has not been impregnated with hemostatic solutions such as
aluminum chloride or epinephrine hydrochloride.
(b)(4) Trade Secret Process
(b)(4) Trade Secret Process
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Differences Analysis
Following is description and intended use:
Quicknit is a dental retraction cord product made to be used specifically to retract gingiva tissue
and prevent fluid from saturating the sulcus during a crown preparation. Quicknit retraction
cord is made of 100% cotton that has not been impregnated with hemostatic solutions such as
aluminum chloride or epinephrine hydrochloride.
Characteristic Comparison Product (Ultrapak
Neha) Quicknit Cord
Intended Use
Ultrapak is a dental retraction cord product made to be used specifically to retract gingiva tissue and prevent fluid from saturating the sulcus during a crown preparation.
Quicknit is a dental retraction cord product made to be used specifically to retract gingiva tissue and prevent fluid from saturating the sulcus during a crown preparation. Quicknit retraction cord is made of 100% cotton that has not been impregnated with hemostatic solutions such as aluminum chloride or epinephrine hydrochloride.
Intended User Dental Professional Dental Professional
Chemical Characteristics Aluminum Chloride Gel None
Recommended Contact Time 1-3 minutes
Quicknit retraction cord is unimpregnated (100% cotton).
Physical Properties Impregnated Cotton Cord Unimpregnated 100% Cotton Cord
How do Differences effect the Safety & Effectiveness of Quicknit?
Being unimpregnated has no effect on the safety & effectiveness of the cord.
(b)(4) Trade Secret Process - Product Specs
(b)(4) Trade Secret Process - Product Specs
(b)(4) Trade Secret Process - Product Specs
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(b)(4) Trade Secret Process- Draft Label
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Specifications of Quicknit cord by each size: (b)(4) Trade Secret Process
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(b)(4) Trade Secret Process- Draft Label
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(b)(4) Trade Secret Process - Product Specs
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K131799
November 12, 2013
To Whom It may Concern:
Enclosed is corrections of our last 510K() submission. All are pdf files. All have prefix numbers as
requested.
001_Quicknit Insert This is the package insert you requested.
003_Ecopy statement This is this letter.
The device name is Quicknit. It is a 100% cotton retraction cord. The cord is unimpregnated. The cord
is substantially equivalent to Ultrapack cord manufactured by Ultradent (K010070). Ultra offers their
cord both impregnated and unimpregnated. Microcopy only offers our cord unimpregnated. Retraction
cord is unclassified and the product code is MVL.
For any questions regarding the submission please contact Peggy Gober, Quality Manager, at Microcopy
Div. of Neo-Flo Inc. Email address is [email protected]
Best Regards,
Peggy Gober
(b)(4) Trade Secret Process - Product Specs