Cleared Traditional

SMARTCOAT 2.5% NAF VARNISH (K131376) - FDA 510(k) Clearance

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

K131376 · Elevate Oral Care · Dental device
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Aug 2013
Decision
105d
Days
Class 2
Risk

K131376 is an FDA 510(k) clearance for the SMARTCOAT 2.5% NAF VARNISH. Classified as Varnish, Cavity (product code LBH), Class II - Special Controls.

Submitted by Elevate Oral Care (West Palm Beach, US). The FDA issued a Cleared decision on August 27, 2013 after a review of 105 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 Elevate Oral Care devices

Submission Details

510(k) Number K131376 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 14, 2013
Decision Date August 27, 2013
Days to Decision 105 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
22d faster than avg
Panel avg: 127d · This submission: 105d
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 33
Devices cleared under the same product code (LBH) and FDA review panel - the closest regulatory comparables to K131376.
FluoroCal
K182917 · Bisco, Inc. · Nov 2019
Restore Toothpaste
K181965 · Dr. Collins, Inc. · Jun 2019
Clinpro Varnish
K151302 · 3M Company · Sep 2015
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