GingiKnit+, GingiBraid+, GingiBraid+ Shortcut, and UniBraid+ impregnated Aluminum Potassium Sulfate Retraction Cord are for the temporary retraction of the gingival margins and hemostasis procedures. The Retraction Cord is placed in the sulcus to displace the gingival tissues for a short period prior to making an impression or for other restorative procedures.

Device Description

Dental retraction materials are used to aid in creating accurate impressions of subgingival margins by temporary gingival displacement, and control of sulcular seepage and hemorrhage. Cords are impregnated with Aluminum Potassium Sulfate. The braided GingiBraid+ and the knitted GingiKnit+ are made of cotton fiber with a different color strand running through the cord for identification of the diameter. Retraction Cords have a yellow background color for medicament identification. The usage is inherently of transient nature. Typical exposure time is less than five minutes. The braided and knitted cord configurations are available in different sizes to fit the sulcus.

AI/ML Overview

This document describes Kerr Corporation's dental retraction cords (GingiKnit+, Gingibraid+, Gingibraid+ Shortcut, and Unibraid+ impregnated Aluminum Potassium Sulfate Retraction Cord) and their substantial equivalence to a predicate device.

Here's an analysis of the acceptance criteria and supporting studies, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria / Performance Metric	Reported Device Performance
Non-Clinical Performance Data	Stability: Performed. (No specific results provided, but implied to be acceptable for substantial equivalence determination.)
	Cutting Test: Performed. (No specific results provided, but implied to be acceptable for substantial equivalence determination.)
	Water Contact Test: Performed. (No specific results provided, but implied to be acceptable for substantial equivalence determination.)
	Biocompatibility Testing (ISO 10993-1: 2009 & ISO 10993-5:2009): Performed.
	- Results: Biocompatibility meets requirements.
Material Compatibility	Biocompatibility meets requirements. (Explicitly stated in Table 8.1 for both Predicate and Proposed Device.)
Technological Characteristics	Designs are similar to the predicate KnitPak+. Braided or knitted cotton also contains a surfactant and Aluminum Potassium Sulfate for hemostasis. The braided material is made of cotton fiber and a solid cord for strong physical retraction, not splitting or collapsing. The knitted cord is formed by many tiny loops, places easily without fraying or memory, and conforms to the sulcus with gentle, outward force. Cuts cleanly if touched by a high-speed instrument. (Implied to meet acceptance criteria for substantial equivalence by being "virtually identical" to the predicate in key characteristics.)
Intended Use	For the temporary retraction and hemostasis of the gingival margin during dental procedures such as, but not limited to, dental impressions, seating of temporary and permanent restorations, restorations of cavities and placement of a rubber dam. (Matches the predicate's intended use.)
Indications for Use	For the temporary retraction of the gingival margins and hemostasis procedures. The Retraction Cord is placed in the sulcus to displace the gingival tissues for a short period prior to making an impression or for other restorative procedures. (Matches the predicate's indications for use, albeit with a different hemostatic agent mentioned primarily in the description.)
Safety and Effectiveness	No new questions of safety or effectiveness raised by noted differences in technological characteristics (specifically the different hemostatic agent, Aluminum Potassium Sulfate vs. Aluminum Chloride, and configuration).

2. Sample Size Used for the Test Set and Data Provenance

The document does not describe a clinical test set in the traditional sense for evaluating the device's performance against specific acceptance criteria for diagnostic accuracy or detection. This is a 510(k) submission focused on substantial equivalence to a predicate device.

Test Set for Non-Clinical Performance Data: The sample sizes for the Stability, Cutting Test, Water Contact Test, and Biocompatibility testing are not specified in the provided text.
Data Provenance: Not explicitly stated for the non-clinical tests. However, the standards used (ISO 10993-1: 2009 and ISO 10993-5:2009) are international standards. This type of testing is generally performed in laboratory settings.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

This information is not applicable as the document describes non-clinical performance and substantial equivalence, not a study evaluating human interpretation or a diagnostic device where ground truth would be established by experts.

4. Adjudication Method for the Test Set

This information is not applicable for the reasons stated above.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This information is not applicable. This device is a dental retraction cord, not an AI software or diagnostic imaging device. No MRMC study was conducted or is relevant to this submission.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

This information is not applicable. This is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used

For the non-clinical tests mentioned:

Biocompatibility: The ground truth is established by the specified ISO standards (ISO 10993-1 and ISO 10993-5), which define acceptable biological responses and methodology.
Other Non-Clinical Tests (Stability, Cutting, Water Contact): The "ground truth" or acceptance criteria for these tests would likely be internal specifications derived from the predicate device's performance or industry standards, ensuring the device functions as intended and safely. Specific criteria are not detailed in the provided text.

8. The Sample Size for the Training Set

This information is not applicable. This is a physical medical device, not a machine learning model, so there is no "training set."

9. How the Ground Truth for the Training Set was Established

This information is not applicable for the reasons stated above.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

February 3, 2017

Kerr Corporation % Mohammad Ansari Regulatory Affairs Specialist II Sybron Dental Specialties 1717 W. Collins Ave. Orange, California 92867

Re: K162536

Trade/Device Name: Gingiknit+, Gingibraid+, Gingibraid+ Shortcut, and Unibraid+ Impregnated Aluminum Potassium Sulfate Retraction Cord Regulation Number: 21 CFR Regulation Name: (Not A Regulation) Retraction Cord Regulatory Class: Unclassified Product Code: MVL Dated: January 6, 2017 Received: January 9, 2017

Dear Mohammad Ansari:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR

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Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerelv.

Michael J. Ryan -S

for Tina Kiang, Ph.D. Acting Director Division of Anesthesiology. General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K162536

Device Name

GingiKnit+, GingiBraid+, GingiBraid+ Shortcut, and UniBraid+ impregnated Aluminum Potassium

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
-------------------------------------------------

☑ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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K162536 510(k) SUMMARY

1. Submitter Information: Sybron Dental Specialties 1717 W. Collins Ave. Orange CA, 92867

Contact Person:	Mohammad Saad Ansari
Telephone Number:	909-962-5644
Fax Number:	909-962-5694

January 27, 2017 Date Prepared:

1. Device Name:
- . Proprietary Name:

GingiKnit+, GingiBraid+, GingiBraid+ Shortcut, and UniBraid+ impregnated Aluminum Potassium Sulfate Retraction Cord

. Classification Name: Retraction Cord CFR Number: 872.3275 . • Device Class: Unclassified
Product Code: .

MVL

Predicate Device: 3.

GingiKnit+, GingiBraid+, GingiBraid+ Shortcut, and UniBraid+ impregnated Aluminum Potassium Sulfate Retraction Cord are substantially equivalent to the legally marketed device(s) Premier Dental Products Co.'s Knit-Pak+, K132526, cleared on November 26, 2013.

4. Description of Device:

న. Intended Use:
The intended use of GingiKnit+, GingiBraid+, GingiBraid+ Shortcut, and UniBraid+ impregnated Aluminum Potassium Sulfate Retraction Cord is for the temporary retraction and hemostasis of the gingival margin during dental procedures such as, but not limited to, dental impressions, seating of temporary and permanent restorations, restorations of cavities and placement of a rubber dam.

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1. Indications for Use:
  GingiKnit+, GingiBraid+, GingiBraid+ Shortcut, and UniBraid+ impregnated Aluminum Potassium Sulfate Retraction Cord are for the temporary retraction of the gingival margins and hemostasis procedures. The Retraction Cord is placed in the sulcus to displace the gingival tissues for a short period prior to making an impression or for other restorative procedures.
1. Description of Substantial Equivalence:
  Technological Characteristics

The designs of GingiKnit+, GingiBraid+, GingiBraid+ Shortcut, and UniBraid+ impregnated Aluminum Potassium Sulfate Retraction Cord are similar to the predicate KnitPak+(K132526). The braided or knitted cotton also contains a surfactant and the chemical Aluminum Potassium Sulfate for hemostasis. The braided retraction material is made of cotton fiber and a solid cord that provides a strong physical retraction and will not split or collapse in the sulcus. It can be used with any type of packing instrument. The knitted retraction cord is constructed by knitting many tiny loops together to form a long interlocking chain that places easily without fraying or memory. The GingiKNIT+ Aluminum Potassium Sulfate Retraction Cord conforms to the sulcus with a gentle, outward force. The knitted retraction cord will cut cleanly if touched by a high-speed cutting instrument.

1. Non-Clinical Performance Data
  Non-clinical performance data included Stability, Cutting Test, Water Contact Test and Biocompatibility testing.

The following standards were utilized for the non-clinical performance testing:

. ISO 10993-1: 2009 Biological evaluation of medical devices
ISO 10993-5:2009 Biological Evaluation of Medical Devices- Part 5: Tests for in . Vitro Cytotoxicity

Table 8.1: Predicate and Proposed Device Comparison Table

Element	PredicateKnit-Pak+	ProposedGingiKnit+, GingiBraid+,GingiBraid+ Shortcut, andUniBraid+ impregnatedAluminum Potassium SulfateRetraction Cord
510(k)	K132526	K162536
510(k) Sponsor	Premier Dental CompanyProducts	Sybron Dental Specialties
Target Users	Licensed dental professionals	Licensed dental professionals
Element	PredicateKnit-Pak+	ProposedGingiKnit+, GingiBraid+.GingiBraid+ Shortcut, andUniBraid+ impregnatedAluminum Potassium SulfateRetraction Cord
Intended Use	The intended use of KnitPak+ isfor the temporary retraction andhemostasis of the gingival marginduring dental procedures such as,but not limited to,dental impressions, seating oftemporary and permanentrestorations, restorations ofcavities and placement of arubber dam.	The intended use of GingiKnit+,GingiBraid+, GingiBraid+Shortcut, and UniBraid+impregnated Aluminum PotassiumSulfate Retraction Cord is for thetemporary retraction andhemostasis of the gingival marginduring dental procedures such as,but not limited to, dentalimpressions, seating of temporaryand permanent restorations,restorations of cavities andplacement of a rubber dam.
Indications for Use	Knit-Pak+, a prescription-only,Aluminum Chloride Hexahydrateimpregnated cord is used fortemporary chemo-mechanical retraction of gingivaltissues and hemostasis of thegingival margin around thetooth. It is intended for accurate andenhanced results when acquiringdental impressions, for cavitypreparation or wherever hemostasisand retraction is required.	GingiKnit+, GingiBraid+,GingiBraid+ Shortcut, andUniBraid+ impregnated AluminumPotassium Sulfate Retraction Cordare for the temporary retraction ofthe gingival margins andhemostasis procedures. TheRetraction Cord is placed in thesulcus to displace the gingivaltissues for a short period prior tomaking an impression or for otherrestorative procedures.
Common Name	Retraction Material	Retraction Material
Classification Name	None	None
Class	Unclassified	Unclassified
Product Code	MVL	MVL
Astringent/HemostaticAgent	Aluminum Chloride	Aluminum Potassium Sulfate
Additional Ingredients	Cotton (others unknown)	Cotton, Silwet (surfactant)
Contact Time	Less than 5 minutes	Less than 5 minutes
Material Compatibility	Biocompatibility meetsrequirements	Biocompatibility meetsrequirements
Configurations	Knitted Cord	Retraction Cord available as:Knitted, Braided, Braided withShortCut, Precut Single UnitDose
Element	PredicateKnit-Pak+	ProposedGingiKnit+, GingiBraid+,GingiBraid+ Shortcut, andUniBraid+ impregnatedAluminum Potassium SulfateRetraction Cord
Amount	100 inches (254 cm)	6 foot total or 2 inch single unit
Packaging	Bottles	BottlesSpecialized ShortCut+ SystemSingle Unit Dose 2 inch

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9. Clinical Performance Data

Clinical performance testing has not been performed for GingiKnit+, GingiBraid+, GingiBraid+ Shortcut, and UniBraid+ impregnated Aluminum Potassium Sulfate Retraction Cord.

1. Conclusion as to Substantial Equivalence
  The subject device and its predicate KnitPak+ differ in their configuration and hemostatic agent. However, the technological characteristics of the subject GingiKnit+, GingiBraid+, GingiBraid+ Shortcut, and UniBraid+ impregnated Aluminum Potassium Sulfate Retraction Cord are virtually identical to the predicate, KnitPak+(K132526), and both devices have the same device intended use. Both devices have retraction as their primary function. The subject device uses the chemical Aluminum Potassium Sulfate while the predicate uses Aluminum Chloride. Results of nonclinical testing demonstrate that the proposed GingiKnit+, GingiBraid+, GingiBraid+ Shortcut, and UniBraid+ impregnated Aluminum Potassium Sulfate Retraction cord has similarities in select performance characteristics as compared to the predicate. Any noted differences in technological characteristics between the proposed and predicate products do not raise new questions of safety or effectiveness.

The subject deviceis substantially equivalent to the predicate KnitPak+(K132526), based on design, performance, biocompatibility testing, and the intended use.

Regulation Number and Section

N/A