Cleared Traditional

K103461 - COLGATE DESENSITIZING DENTAL CREAM

K103461 is the FDA 510(k) clearance for COLGATE DESENSITIZING DENTAL CREAM by Colgate-Palmolive Co.. It is a Class 2 Dental device (product code LBH) cleared through the Traditional 510(k) pathway after a 293-day FDA review.

K103461 · Colgate-Palmolive Co. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2011
Decision
293d
Days
Class 2
Risk

K103461 is an FDA 510(k) clearance for the COLGATE DESENSITIZING DENTAL CREAM. Classified as Varnish, Cavity (product code LBH), Class II - Special Controls.

Submitted by Colgate-Palmolive Co. (Piscataway, US). The FDA issued a Cleared decision on September 13, 2011 after a review of 293 days - an extended review 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: 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 Colgate-Palmolive Co. devices

Submission Details

510(k) Number K103461 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 24, 2010
Decision Date September 13, 2011
Days to Decision 293 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
166d slower than avg
Panel avg: 127d · This submission: 293d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 67
Devices cleared under the same product code (LBH) and FDA review panel - the closest regulatory comparables to K103461.
Clinpro Varnish
K151302 · 3M Company · Sep 2015
SEAL BLOCK PRO (NOT FINALIZED), SEAL BLOCK OTC (NOT FINALIZED)
K123653 · Bisco, Inc. · Jun 2013
SENZZZZZ AWAY
K120176 · Centrix, Inc. · Jul 2012
MI VARNISH
K102808 · GC America, Inc. · Dec 2010
VANISH VARNISH, 5% SODIUM FLUORIDE VARNISH, MODEL 12245, VANISH VARNISH, 5% FLUORIDE VARNISH, MODEL 12247
K090519 · 3M Company · Apr 2009
VOCO PROFLUORID L
K083036 · Voco GmbH · Jan 2009