Home / 510(k) Clearances / K242913

510(k) K242913

Jasmate® Toothpaste by Jasberry Healthcare Private Limited — Product Code LBH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 22, 2024
Date Received
September 24, 2024
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

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