STARBRIGHT 5% SODIUM FLUORIDE VARNISH

Varnish, Cavity

NANOVA BIOMATERIALS, INC.

The following data is part of a premarket notification filed by Nanova Biomaterials, Inc. with the FDA for Starbright 5% Sodium Fluoride Varnish.

Pre-market Notification Details

Device IDK140349
510k NumberK140349
Device Name:STARBRIGHT 5% SODIUM FLUORIDE VARNISH
ClassificationVarnish, Cavity
Applicant NANOVA BIOMATERIALS, INC. 3806 MOJAVE CT Columbia,  MO  65202
ContactAndrew Ritts
CorrespondentAndrew Ritts
NANOVA BIOMATERIALS, INC. 3806 MOJAVE CT Columbia,  MO  65202
Product CodeLBH  
CFR Regulation Number872.3260 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-02-19
Decision Date2014-09-22
Summary:summary

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