510(k) K022675

PRIME-DENT AUTOMIX DUAL CURE CORE BUILD UP MATERIAL by Prime Dental Manufacturing, Inc. — Product Code EBF

K022675 is an FDA 510(k) premarket notification submitted by Prime Dental Manufacturing, Inc. for the device "PRIME-DENT AUTOMIX DUAL CURE CORE BUILD UP MATERIAL". The FDA issued a decision of Substantially Equivalent on November 7, 2002. The device falls under product code EBF (Material, Tooth Shade, Resin), a Class II device regulated under 21 CFR 872.3690. Prime Dental Manufacturing, Inc. has at least 8 other 510(k) clearances on record.