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510(k) K120176

SENZZZZZ AWAY by Centrix, Inc. — Product Code LBH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 25, 2012
Date Received
January 20, 2012
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Varnish, Cavity
Device Class
Class II
Regulation Number
872.3260
Review Panel
DE
Submission Type

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Other clearances for product code LBH

  • K250714 — FluoroDose Varnish (November 21, 2025)
  • K243777 — Rennou™ Varnish (3% / Spearmint); Rennou™ Varnish (3% / Strawberry); Rennou™ Var (May 27, 2025)
  • K241489 — ReminGel (January 8, 2025)
  • K241568 — CrystLCare™ PRO Biorestorative, Fluoride-Plus (January 2, 2025)
  • K242913 — Jasmate® Toothpaste (November 22, 2024)
  • K233768 — Papacarie Duo (July 18, 2024)
  • K231060 — ProMin Dental Desensitizing Gel (June 13, 2024)
  • K230333 — Profisil Fluoride Varnish Combi pack (14801), Profisil Fluoride Varnish Normal (July 24, 2023)
  • K222891 — Dental Desensitizer (May 25, 2023)
  • K231338 — 3M™ Clinpro™ Clear 2.1% Sodium Fluoride Treatment (May 10, 2023)