510(k) K954876

AMERICAN DENTAL PRODUCTS ROOT CANAL SEALER, WACH'S FORMULA by American Dental Products, Inc. — Product Code EMA

K954876 is an FDA 510(k) premarket notification submitted by American Dental Products, Inc. for the device "AMERICAN DENTAL PRODUCTS ROOT CANAL SEALER, WACH'S FORMULA". The FDA issued a decision of Substantially Equivalent on November 15, 1995. The device falls under product code EMA (Cement, Dental), a Class II device regulated under 21 CFR 872.3275. American Dental Products, Inc. has at least 10 other 510(k) clearances on record.