510(k) K954407

AMERICAN DENTAL PRODUCTS WHITE COMPOSITE RESIN CORE PASTE WITH FLUORIDE by American Dental Products, Inc. — Product Code EBF

K954407 is an FDA 510(k) premarket notification submitted by American Dental Products, Inc. for the device "AMERICAN DENTAL PRODUCTS WHITE COMPOSITE RESIN CORE PASTE WITH FLUORIDE". The FDA issued a decision of Substantially Equivalent on October 30, 1995. The device falls under product code EBF (Material, Tooth Shade, Resin), a Class II device regulated under 21 CFR 872.3690. American Dental Products, Inc. has at least 10 other 510(k) clearances on record.