510(k) K012160

COMPCORE AF COMPOSITE CORE BUILD-UP MATERIAL, MODEL 3001408 by Premier Dental Products Co. — Product Code EBF

K012160 is an FDA 510(k) premarket notification submitted by Premier Dental Products Co. for the device "COMPCORE AF COMPOSITE CORE BUILD-UP MATERIAL, MODEL 3001408". The FDA issued a decision of Substantially Equivalent on September 27, 2001. The device falls under product code EBF (Material, Tooth Shade, Resin), a Class II device regulated under 21 CFR 872.3690. Premier Dental Products Co. has at least 10 other 510(k) clearances on record.