510(k) K101540

GRANITEC DUAL-CURE CORE BUILD-UP, N'DURANCE DIMER CORE by Novocol Inc. Dba Septodont and Confi-Dental Produc — Product Code EBF

K101540 is an FDA 510(k) premarket notification submitted by Novocol Inc. Dba Septodont and Confi-Dental Produc for the device "GRANITEC DUAL-CURE CORE BUILD-UP, N'DURANCE DIMER CORE". The FDA issued a decision of Substantially Equivalent on October 29, 2010. The device falls under product code EBF (Material, Tooth Shade, Resin), a Class II device regulated under 21 CFR 872.3690. Novocol Inc. Dba Septodont and Confi-Dental Produc has at least 1 other 510(k) clearance on record.