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510(k) K260830

APAPRO Desensitizer Homecare (Remineralizing Anti-sensitivity Toothpaste) by Sangi Co., Ltd. — Product Code LBH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 18, 2026
Date Received
March 13, 2026
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

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

Other clearances by Sangi Co., Ltd.

  • K220419 — Apapro Desensitizer (February 16, 2022)

Other clearances for product code LBH

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  • 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)