510(k) K131376

SMARTCOAT 2.5% NAF VARNISH by Elevate Oral Care — Product Code LBH

K131376 is an FDA 510(k) premarket notification submitted by Elevate Oral Care for the device "SMARTCOAT 2.5% NAF VARNISH". The FDA issued a decision of Substantially Equivalent on August 27, 2013. The device falls under product code LBH (Varnish, Cavity), a Class II device regulated under 21 CFR 872.3260. Elevate Oral Care has at least 4 other 510(k) clearances on record.