510(k) K140349

STARBRIGHT 5% SODIUM FLUORIDE VARNISH by Nanova Biomaterials, Inc. — Product Code LBH

K140349 is an FDA 510(k) premarket notification submitted by Nanova Biomaterials, Inc. for the device "STARBRIGHT 5% SODIUM FLUORIDE VARNISH". The FDA issued a decision of Substantially Equivalent on September 22, 2014. The device falls under product code LBH (Varnish, Cavity), a Class II device regulated under 21 CFR 872.3260. Nanova Biomaterials, Inc. has at least 7 other 510(k) clearances on record.