510(k) K112574

PRIME-DENT DUAL CURE COMPOSITE LUTING CEMENT by Prime Dental Manufacturing, Inc. — Product Code EMA

K112574 is an FDA 510(k) premarket notification submitted by Prime Dental Manufacturing, Inc. for the device "PRIME-DENT DUAL CURE COMPOSITE LUTING CEMENT". The FDA issued a decision of Substantially Equivalent on January 23, 2012. The device falls under product code EMA (Cement, Dental), a Class II device regulated under 21 CFR 872.3275. Prime Dental Manufacturing, Inc. has at least 8 other 510(k) clearances on record.