Home / 510(k) Clearances / K192381

510(k) K192381

DFV Desensitizing Varnish-Strawberry Flavor, DFV Desensitizing Varnish-Bubblegum (Tutti-Fruity) Flavor, DFV Desensitizing Varnish-Spearmint Flavor, DFV Desensitizing Varnish-Chocolate Flavor, DFV Desensitizing Varnish-Marshmallow Flavor by Scientific Pharmaceuticals — Product Code LBH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 18, 2020
Date Received
August 30, 2019
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 Scientific Pharmaceuticals

  • K051952 — EUGENONE (September 7, 2005)
  • K041886 — PROVISO (August 4, 2004)
  • K013555 — SCI-PHARM POST SECURE (January 23, 2002)
  • K001446 — LIGHT-CURED ORTHODONTIC BAND CEMENT (July 21, 2000)
  • K993324 — CARBOCEM ZINC POLYCARBOXYLATE CEMENT (November 9, 1999)
  • K982915 — SCI-PHARM DFV VARNISH (February 12, 1999)
  • K983305 — SCI-PHARM DESENSITIZING VARNISH (December 17, 1998)
  • K982913 — ZINFOS ZINC PHOSPHATE CEMENT (October 19, 1998)
  • K944466 — SEALDENT (March 2, 1995)
  • K930583 — MEGABOND SYSTEM (February 22, 1994)

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)