Home / 510(k) Clearances / K112946

510(k) K112946

ACTIV VARNISH by Pulpdent Corporation — Product Code LBH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 9, 2011
Date Received
October 4, 2011
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 by Pulpdent Corporation

  • K210045 — ACTIVA PRESTO PACK (September 22, 2021)
  • K173020 — OBA-MCP, Orthodontic Bracket Adhesive with MCP (January 17, 2018)
  • K172169 — Pulpdent (Activa) Pit and Fissure Sealant with MCP (January 5, 2018)
  • K153249 — Pulpdent Solo Flowable Composite with MCP (April 1, 2016)
  • K130223 — RMGI FILL (March 29, 2013)
  • K123265 — RMGI LOW VISCOSITY (December 7, 2012)
  • K120784 — TUFF-TEMP 2.0 (June 8, 2012)
  • K120003 — NUCAL (April 5, 2012)
  • K120213 — ETCH-RITE SUPREME (March 30, 2012)
  • K113818 — EMBRACE WETBOND PIT AND FISSURE SEALANT, LOW FILL (March 21, 2012)

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)