510(k) K071278

EMBRACE DUAL CURE COMPOSITE MATERIALS by Pulpdent Corporation — Product Code EBF

K071278 is an FDA 510(k) premarket notification submitted by Pulpdent Corporation for the device "EMBRACE DUAL CURE COMPOSITE MATERIALS". The FDA issued a decision of Substantially Equivalent on June 29, 2007. The device falls under product code EBF (Material, Tooth Shade, Resin), a Class II device regulated under 21 CFR 872.3690. Pulpdent Corporation has at least 10 other 510(k) clearances on record.