510(k) K092141

VANISH VARNISH, 5% SODIUM FLUORIDE WHITE VARNISH by 3M Espe Dental Products — Product Code LBH

K092141 is an FDA 510(k) premarket notification submitted by 3M Espe Dental Products for the device "VANISH VARNISH, 5% SODIUM FLUORIDE WHITE VARNISH". The FDA issued a decision of Substantially Equivalent on March 10, 2010. The device falls under product code LBH (Varnish, Cavity), a Class II device regulated under 21 CFR 872.3260. 3M Espe Dental Products has at least 10 other 510(k) clearances on record.