Cleared Traditional

3M™ Clinpro™ Clear 2.1% Sodium Fluoride Treatment (K231338) - FDA 510(k) Clearance

Class II Dental device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K231338 · 3M Espe Dental Products · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2023
Decision
2d
Days
Class 2
Risk

K231338 is an FDA 510(k) clearance for the 3M™ Clinpro™ Clear 2.1% Sodium Fluoride Treatment. Classified as Varnish, Cavity (product code LBH), Class II - Special Controls.

Submitted by 3M Espe Dental Products (Saint Paul, US). The FDA issued a Cleared decision on May 10, 2023 after a review of 2 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3260 - the FDA dental device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all 3M Espe Dental Products devices

Submission Details

510(k) Number K231338 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
125d faster than avg
Panel avg: 127d · This submission: 2d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

Device Classification

Product Code LBH Varnish, Cavity
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3260
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Dental devices follow this clearance model.

Regulatory Peers - LBH Varnish, Cavity

All 32
Devices cleared under the same product code (LBH) and FDA review panel - the closest regulatory comparables to K231338.
ProMin Dental Desensitizing Gel
K231060 · Belport Company, Inc., Gingi-Pak · Jun 2024
Profisil Fluoride Varnish Combi pack (14801), Profisil Fluoride Varnish Normal pack mint (14802), Profisil Fluoride Varnish Normal pack berry (14804), Profisil Fluoride Varnish Normal pack unflavored (14806), Profisil Fluoride Varnish Sample pack (14800)
K230333 · Kettenbach GmbH & Co. KG · Jul 2023
Dental Desensitizer
K222891 · Guangzhou Beogene Biotech Co., Ltd. · May 2023
Apapro Desensitizer
K220419 · Sangi Co, Ltd. · Feb 2022
BioMin Restore Plus
K200077 · Dr. Collins, Inc. · Nov 2020
FiteBac Antimicrobial Cavity Cleanser
K200614 · Largent Health, LLC · Jun 2020