Cleared Traditional

STARBRIGHT 5% SODIUM FLUORIDE VARNISH (K140349) - FDA 510(k) Clearance

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

K140349 · Nanova Biomaterials, Inc. · Dental device
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Sep 2014
Decision
215d
Days
Class 2
Risk

K140349 is an FDA 510(k) clearance for the STARBRIGHT 5% SODIUM FLUORIDE VARNISH. Classified as Varnish, Cavity (product code LBH), Class II - Special Controls.

Submitted by Nanova Biomaterials, Inc. (Columbia, US). The FDA issued a Cleared decision on September 22, 2014 after a review of 215 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 Nanova Biomaterials, Inc. devices

Submission Details

510(k) Number K140349 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 19, 2014
Decision Date September 22, 2014
Days to Decision 215 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
88d slower than avg
Panel avg: 127d · This submission: 215d
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 28
Devices cleared under the same product code (LBH) and FDA review panel - the closest regulatory comparables to K140349.
FluoroCal
K182917 · Bisco, Inc. · Nov 2019
Restore Toothpaste
K181965 · Dr. Collins, Inc. · Jun 2019
Clinpro Varnish
K151302 · 3M Company · Sep 2015
VANISH VARNISH, 5% SODIUM FLUORIDE VARNISH, MODEL 12245, VANISH VARNISH, 5% FLUORIDE VARNISH, MODEL 12247
K090519 · 3M Company · Apr 2009
FLUORIDE VARNISH
K031932 · Dentsply Intl. · Sep 2003
SEAL & PROTECT PROTECTIVE SEALANT
K021805 · Dentsply Intl. · Aug 2002