← Product Code MVL · K162536 # GingiKnit+, GingiBraid+, GingiBraid+ Shortcut, and UniBraid+ impregnated Aluminum Potassium Sulfate Retraction Cord (K162536) _Kerr Corporation · MVL · Feb 3, 2017 · DE · SESE_ **Canonical URL:** https://fda.innolitics.com/device/K162536 ## Device Facts - **Applicant:** Kerr Corporation - **Product Code:** MVL - **Decision Date:** Feb 3, 2017 - **Decision:** SESE - **Submission Type:** Traditional - **Device Class:** Class U - **Review Panel:** DE - **Attributes:** Therapeutic ## 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. ## Device Story Dental retraction cords used by licensed dental professionals in clinical settings to facilitate accurate impressions and restorative procedures. Cords are made of cotton fiber, impregnated with Aluminum Potassium Sulfate and a surfactant (Silwet). Available in braided (GingiBraid+, UniBraid+) and knitted (GingiKnit+) configurations to provide physical displacement of gingival tissue. Placed into the sulcus using a packing instrument; provides gentle outward force to retract tissue and control sulcular seepage/hemorrhage. Exposure time is transient (typically <5 minutes). The device aids the clinician in creating clear margins for dental impressions, seating restorations, or cavity preparation. Benefits include improved visualization and moisture control for the clinician, leading to more accurate dental restorations for the patient. ## Clinical Evidence No clinical performance data was performed. Substantial equivalence is supported by non-clinical performance data including stability, cutting tests, water contact tests, and biocompatibility testing per ISO 10993-1:2009 and ISO 10993-5:2009. ## Technological Characteristics Materials: Cotton fiber, Aluminum Potassium Sulfate (hemostatic agent), Silwet (surfactant). Configurations: Knitted and braided. Dimensions: Available in various sizes; lengths include 6-foot total or 2-inch single unit doses. Biocompatibility: Meets ISO 10993-1 and ISO 10993-5 standards. Mechanical: Provides physical retraction via outward force; non-splitting/non-collapsing design. ## Predicate Devices - Knit-Pak+ ([K132526](/device/K132526.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three heads, representing the department's commitment to health, human services, and science. The eagle is surrounded by a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in capital letters. 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 {1}------------------------------------------------ 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 {2}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K162536 Device Name GingiKnit+, GingiBraid+, GingiBraid+ Shortcut, and UniBraid+ impregnated Aluminum Potassium ### Indications for Use (Describe) 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. | 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) | ## CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. ### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ # 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: - 2. 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: 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. There have been no prior submissions on the subject product line. - 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. {4}------------------------------------------------ - 6. 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. - 7. 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. - 8. 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 | Predicate
Knit-Pak+ | Proposed
GingiKnit+, GingiBraid+,
GingiBraid+ Shortcut, and
UniBraid+ impregnated
Aluminum Potassium Sulfate
Retraction Cord | |--------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 510(k) | K132526 | K162536 | | 510(k) Sponsor | Premier Dental Company
Products | Sybron Dental Specialties | | Target Users | Licensed dental professionals | Licensed dental professionals | | Element | Predicate
Knit-Pak+ | Proposed
GingiKnit+, GingiBraid+.
GingiBraid+ Shortcut, and
UniBraid+ impregnated
Aluminum Potassium Sulfate
Retraction Cord | | Intended Use | The intended use of KnitPak+ 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. | 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. | | Indications for Use | Knit-Pak+, a prescription-only,
Aluminum Chloride Hexahydrate
impregnated cord is used for
temporary chemo-
mechanical retraction of gingival
tissues and hemostasis of the
gingival margin around the
tooth. It is intended for accurate and
enhanced results when acquiring
dental impressions, for cavity
preparation or wherever hemostasis
and retraction is required. | 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. | | Common Name | Retraction Material | Retraction Material | | Classification Name | None | None | | Class | Unclassified | Unclassified | | Product Code | MVL | MVL | | Astringent/Hemostatic
Agent | 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 meets
requirements | Biocompatibility meets
requirements | | Configurations | Knitted Cord | Retraction Cord available as:
Knitted, Braided, Braided with
ShortCut, Precut Single Unit
Dose | | Element | Predicate
Knit-Pak+ | Proposed
GingiKnit+, GingiBraid+,
GingiBraid+ Shortcut, and
UniBraid+ impregnated
Aluminum Potassium Sulfate
Retraction Cord | | Amount | 100 inches (254 cm) | 6 foot total or 2 inch single unit | | Packaging | Bottles | Bottles
Specialized ShortCut+ System
Single Unit Dose 2 inch | {5}------------------------------------------------ {6}------------------------------------------------ #### 9. Clinical Performance Data Clinical performance testing has not been performed for GingiKnit+, GingiBraid+, GingiBraid+ Shortcut, and UniBraid+ impregnated Aluminum Potassium Sulfate Retraction Cord. - 10. 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. --- **Source:** [https://fda.innolitics.com/device/K162536](https://fda.innolitics.com/device/K162536) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com