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510(k) K162164

GingiKnit+, GingiBraid+, and Shortcut with GingiBraid+ Non-Impregnated Retraction Cord by Kerr Corporation — Product Code MVL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 13, 2017
Date Received
August 3, 2016
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cord, Retraction
Device Class
Class U
Regulation Number
Review Panel
DE
Submission Type

Other clearances by Kerr Corporation

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  • K162948 — Styptin, Hemogin-L, Hemodettes, and GingiGEL Aluminum Chloride Impregnated Retra (August 8, 2017)
  • K163064 — Demi Ultra (July 18, 2017)
  • K162536 — GingiKnit+, GingiBraid+, GingiBraid+ Shortcut, and UniBraid+ impregnated Aluminu (February 3, 2017)
  • K162436 — EndoVac Pure (December 21, 2016)
  • K162257 — P1145 Dental Restorative (November 7, 2016)

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  • K200764 — STATSTIX (October 15, 2020)
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  • K190220 — Vista FS, Vista FS Liquid (June 10, 2019)
  • K171577 — Smartcord, Smartcord X (May 3, 2018)
  • K162662 — GingiDent Gingival Retraction Paste (October 20, 2017)