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FDA 510(k)

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

K-Number: K162536 · 2017-02-03

ApplicantKerr Corporation
Decision Date2017-02-03
Product CodeMVL
DecisionSubstantially Equivalent

Device Summary

GingiKnit+, GingiBraid+, GingiBraid+ Shortcut, and UniBraid+ impregnated Aluminum Potassium Sulfate Retraction Cord is a medical device manufactured by Kerr Corporation. It received FDA 510(k) clearance on 2017-02-03 under approval number K162536. The device is classified under product code MVL. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GingiKnit+, GingiBraid+, GingiBraid+ Shortcut, and UniBraid+ impregnated Aluminum Potassium Sulfate Retraction Cord?

GingiKnit+, GingiBraid+, GingiBraid+ Shortcut, and UniBraid+ impregnated Aluminum Potassium Sulfate Retraction Cord is a medical device that received FDA 510(k) clearance on 2017-02-03. It is manufactured by Kerr Corporation. The 510(k) number is K162536.

When was GingiKnit+, GingiBraid+, GingiBraid+ Shortcut, and UniBraid+ impregnated Aluminum Potassium Sulfate Retraction Cord approved by the FDA?

GingiKnit+, GingiBraid+, GingiBraid+ Shortcut, and UniBraid+ impregnated Aluminum Potassium Sulfate Retraction Cord received FDA 510(k) clearance on 2017-02-03, under approval number K162536.

What company makes GingiKnit+, GingiBraid+, GingiBraid+ Shortcut, and UniBraid+ impregnated Aluminum Potassium Sulfate Retraction Cord?

GingiKnit+, GingiBraid+, GingiBraid+ Shortcut, and UniBraid+ impregnated Aluminum Potassium Sulfate Retraction Cord is manufactured by Kerr Corporation.

What is the FDA product code for GingiKnit+, GingiBraid+, GingiBraid+ Shortcut, and UniBraid+ impregnated Aluminum Potassium Sulfate Retraction Cord?

The FDA product code for GingiKnit+, GingiBraid+, GingiBraid+ Shortcut, and UniBraid+ impregnated Aluminum Potassium Sulfate Retraction Cord is MVL.

Other Devices by Kerr Corporation

K162436EndoVac Pure K162257P1145 Dental Restorative K160441Identic and KromaFaze Alginate Dental Impression Materials K162948Styptin, Hemogin-L, Hemodettes, and GingiGEL Aluminum Chloride Impregnated Retraction Cord/Materials K163064Demi Ultra K162164GingiKnit+, GingiBraid+, and Shortcut with GingiBraid+ Non-Impregnated Retraction Cord

View all 12 devices →

Related Devices (Code: MVL)

K162662GingiDent Gingival Retraction PastePac-Dent International, Inc. K162948Styptin, Hemogin-L, Hemodettes, and GingiGEL Aluminum Chloride Impregnated Retraction Cord/MaterialsKerr Corporation K162164GingiKnit+, GingiBraid+, and Shortcut with GingiBraid+ Non-Impregnated Retraction CordKerr Corporation K171577Smartcord, Smartcord XEastdent Co., Ltd. K190220Vista FS, Vista FS LiquidInter-Med/Vista Dental Products K200764STATSTIXCentrix Incorporated

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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