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510(k) K162948

Styptin, Hemogin-L, Hemodettes, and GingiGEL Aluminum Chloride Impregnated Retraction Cord/Materials by Kerr Corporation — Product Code MVL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 8, 2017
Date Received
October 21, 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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  • K191548 — Nexus Universal Self-Cure (October 11, 2019)
  • K182162 — OptiBond eXTRa Universal (November 7, 2018)
  • K163064 — Demi Ultra (July 18, 2017)
  • K162536 — GingiKnit+, GingiBraid+, GingiBraid+ Shortcut, and UniBraid+ impregnated Aluminu (February 3, 2017)
  • K162164 — GingiKnit+, GingiBraid+, and Shortcut with GingiBraid+ Non-Impregnated Retractio (January 13, 2017)
  • K162436 — EndoVac Pure (December 21, 2016)
  • K162257 — P1145 Dental Restorative (November 7, 2016)

Other clearances for product code MVL

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  • K211419 — Gingi-Aid Gel (January 10, 2022)
  • K213149 — VOCO Retraction Paste (December 9, 2021)
  • K200764 — STATSTIX (October 15, 2020)
  • K193389 — Vista Clear (March 4, 2020)
  • K190220 — Vista FS, Vista FS Liquid (June 10, 2019)
  • K171577 — Smartcord, Smartcord X (May 3, 2018)
  • K162662 — GingiDent Gingival Retraction Paste (October 20, 2017)