510(k) K100503

PULPDENT COPAL VARNISH WITH FLUORIDE by Pulpdent Corporation — Product Code LBH

K100503 is an FDA 510(k) premarket notification submitted by Pulpdent Corporation for the device "PULPDENT COPAL VARNISH WITH FLUORIDE". The FDA issued a decision of Substantially Equivalent on May 12, 2010. The device falls under product code LBH (Varnish, Cavity), a Class II device regulated under 21 CFR 872.3260. Pulpdent Corporation has at least 10 other 510(k) clearances on record.