510(k) K954333

AMERICAN DENTAL PRODUCTS ORTHODONTIC ADHESIVE W/ONE STEP BONDING SYSTEM by American Dental Products, Inc. — Product Code DYH

K954333 is an FDA 510(k) premarket notification submitted by American Dental Products, Inc. for the device "AMERICAN DENTAL PRODUCTS ORTHODONTIC ADHESIVE W/ONE STEP BONDING SYSTEM". The FDA issued a decision of Substantially Equivalent on October 12, 1995. The device falls under product code DYH (Adhesive, Bracket And Tooth Conditioner, Resin), a Class II device regulated under 21 CFR 872.3750. American Dental Products, Inc. has at least 10 other 510(k) clearances on record.