Cleared Traditional

3M? Clinpro? Clear 2.1% Sodium Fluoride Treatment

K231338 · 3M Espe Dental Products · Dental
May 2023
Decision
2d
Days
Class 2
Risk

About This 510(k) Submission

K231338 is an FDA 510(k) clearance for the 3M? Clinpro? Clear 2.1% Sodium Fluoride Treatment, a Varnish, Cavity (Class II — Special Controls, product code LBH), submitted by 3M Espe Dental Products (Saint Paul, US). The FDA issued a Cleared decision on May 10, 2023, 2 days after receiving the submission on May 8, 2023. This device falls under the Dental review panel. Regulated under 21 CFR 872.3260.

Submission Details

510(k) Number K231338 FDA.gov
FDA Decision Cleared SESE
Date Received May 08, 2023
Decision Date May 10, 2023
Days to Decision 2 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code LBH — Varnish, Cavity
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.3260

Similar Devices — LBH Varnish, Cavity

All 133
FluoroDose Varnish
K250714 · Centrix, Inc. · Nov 2025
Rennou? Varnish (3% / Spearmint); Rennou? Varnish (3% / Strawberry); Rennou? Varnish (3% / Cherry); Rennou? Varnish (3% / Bubble Gum)
K243777 · Theodent, LLC · May 2025
ReminGel
K241489 · Inter-Med, Inc. · Jan 2025
CrystLCare? PRO Biorestorative, Fluoride-Plus
K241568 · GreenMark Biomedical, Inc. · Jan 2025
Jasmate? Toothpaste
K242913 · Jasberry Healthcare Private Limited · Nov 2024
Papacarie Duo
K233768 · Elevate Oral Care · Jul 2024