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510(k) K231060

ProMin Dental Desensitizing Gel by Belport Company, Inc., Gingi-Pak — Product Code LBH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 13, 2024
Date Received
April 13, 2023
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

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  • 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)
  • 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)
  • K220419 — Apapro Desensitizer (February 16, 2022)