510(k) K113818

EMBRACE WETBOND PIT AND FISSURE SEALANT, LOW FILL by Pulpdent Corporation — Product Code EBC

K113818 is an FDA 510(k) premarket notification submitted by Pulpdent Corporation for the device "EMBRACE WETBOND PIT AND FISSURE SEALANT, LOW FILL". The FDA issued a decision of Substantially Equivalent on March 21, 2012. The device falls under product code EBC (Sealant, Pit And Fissure, And Conditioner), a Class II device regulated under 21 CFR 872.3765. Pulpdent Corporation has at least 10 other 510(k) clearances on record.