Cleared Traditional

K151302 - Clinpro Varnish

K151302 is an FDA 510(k) clearance for Clinpro Varnish, manufactured by 3M Company. The device is a Class 2 Dental device with product code LBH cleared through the Traditional 510(k) pathway after a 126-day FDA review.

K151302 · 3M Company · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2015
Decision
126d
Days
Class 2
Risk

K151302 is an FDA 510(k) clearance for the Clinpro Varnish. Classified as Varnish, Cavity (product code LBH), Class II - Special Controls.

Submitted by 3M Company (Saint Paul, US). The FDA issued a Cleared decision on September 18, 2015 after a review of 126 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all 3M Company devices

FDA 510(k) Submission Details - K151302

510(k) Number K151302 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 15, 2015
Decision Date September 18, 2015
Days to Decision 126 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
1d faster than avg
Panel avg: 127d · This submission: 126d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LBH Device Classification - Class 2, Special Controls

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 83
Devices cleared under the same product code (LBH) and FDA review panel - the closest regulatory comparables to K151302.
Restore Toothpaste
K181965 · Dr. Collins, Inc. · Jun 2019
V-varnish Premium
K160377 · Vericom Co., Ltd. · Dec 2016
Oral-B 5% Sodium Fluoride Varnish
K153334 · Young Dental Manufacturing Co. 1, LLC · May 2016
FLUOR PROTECTOR S
K131487 · Ivoclar Vivadent, AG · Oct 2014
SEAL BLOCK PRO (NOT FINALIZED), SEAL BLOCK OTC (NOT FINALIZED)
K123653 · Bisco, Inc. · Jun 2013
PRG BARRIER COAT
K122908 · Shofu Dental Corporation · Apr 2013