GingiKnit+, GingiBraid+, GingiBraid+ Shortcut, and UniBraid+ impregnated Aluminum Potassium Sulfate Retraction Cord— 510(k) K162536

Name: FDA 510(k) clearance K162536
Creator: U.S. Food and Drug Administration
Published: 2017-02-03

Substantially Equivalent

Kerr Corporation

FDA 510(k) clearance K162536 for GingiKnit+, GingiBraid+, GingiBraid+ Shortcut, and UniBraid+ impregnated Aluminum Potassium Sulfate Retraction Cord, Substantially Equivalent on 2017-02-03. Applicant: Kerr Corporation. Device class: Unclassified.

Clearance details

Applicant: Kerr Corporation
Product code: Code MVL
Device class: Unclassified
Advisory panel: Unknown
Date received: 2016-09-12
Decision date: 2017-02-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Orange, CA, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.