GingiKnit+, GingiBraid+, and Shortcut with GingiBraid+ Non-Impregnated Retraction Cord— 510(k) K162164

Name: FDA 510(k) clearance K162164
Creator: U.S. Food and Drug Administration
Published: 2017-01-13

Substantially Equivalent

Kerr Corporation

FDA 510(k) clearance K162164 for GingiKnit+, GingiBraid+, and Shortcut with GingiBraid+ Non-Impregnated Retraction Cord, Substantially Equivalent on 2017-01-13. Applicant: Kerr Corporation. Device class: Unclassified.

Clearance details

Applicant: Kerr Corporation
Product code: Code MVL
Device class: Unclassified
Advisory panel: Unknown
Date received: 2016-08-03
Decision date: 2017-01-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Orange, CA, US

Download summary PDF View on FDA.gov ↗

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