510(k) K140350

VELLA 5% SODIUM FLUORIDE VARNISH WITH NUFLUOR AND XYLITOL by Preventive Technologies, Inc. — Product Code LBH

K140350 is an FDA 510(k) premarket notification submitted by Preventive Technologies, Inc. for the device "VELLA 5% SODIUM FLUORIDE VARNISH WITH NUFLUOR AND XYLITOL". The FDA issued a decision of Substantially Equivalent on December 12, 2014. The device falls under product code LBH (Varnish, Cavity), a Class II device regulated under 21 CFR 872.3260. Preventive Technologies, Inc. has at least 2 other 510(k) clearances on record.