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FDA 510(k)

GingiKnit+, GingiBraid+, and Shortcut with GingiBraid+ Non-Impregnated Retraction Cord

K-Number: K162164 · 2017-01-13

ApplicantKerr Corporation
Decision Date2017-01-13
Product CodeMVL
DecisionSubstantially Equivalent

Device Summary

GingiKnit+, GingiBraid+, and Shortcut with GingiBraid+ Non-Impregnated Retraction Cord is the device name listed in this FDA 510(k) record. The listed applicant is Kerr Corporation. It received FDA 510(k) clearance on 2017-01-13 under 510(k) number K162164. The device is classified under product code MVL. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GingiKnit+, GingiBraid+, and Shortcut with GingiBraid+ Non-Impregnated Retraction Cord?

GingiKnit+, GingiBraid+, and Shortcut with GingiBraid+ Non-Impregnated Retraction Cord is a medical device that received FDA 510(k) clearance on 2017-01-13. The listed applicant is Kerr Corporation. The 510(k) number is K162164.

When did GingiKnit+, GingiBraid+, and Shortcut with GingiBraid+ Non-Impregnated Retraction Cord receive FDA 510(k) clearance?

GingiKnit+, GingiBraid+, and Shortcut with GingiBraid+ Non-Impregnated Retraction Cord received FDA 510(k) clearance on 2017-01-13, under 510(k) number K162164.

Who is the listed applicant for GingiKnit+, GingiBraid+, and Shortcut with GingiBraid+ Non-Impregnated Retraction Cord?

The FDA 510(k) record lists Kerr Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GingiKnit+, GingiBraid+, and Shortcut with GingiBraid+ Non-Impregnated Retraction Cord?

The FDA product code for GingiKnit+, GingiBraid+, and Shortcut with GingiBraid+ Non-Impregnated Retraction Cord is MVL.

Other records listing Kerr Corporation as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K252890ZenSeal ProK222830Rainbow 360K221255SimpliShade Bulk Fill, SimpliShade Bulk Fill FlowK191548Nexus Universal Self-CureK182162OptiBond eXTRa UniversalK162948Styptin, Hemogin-L, Hemodettes, and GingiGEL Aluminum Chloride Impregnated Retraction Cord/Materials

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Related Devices (Code: MVL)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K254239CyClean CordSS GLOBALK253797One-StopMediclus Co., Ltd.K243910RetraxilKulzer, LLCK211420Stasis GelBelport Company, Inc., Gingi-PakK211419Gingi-Aid GelBelport Company, Inc., Gingi-PakK213149VOCO Retraction PasteVoco GmbH

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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