510(k) K954637

AMERICAN DENTAL PRODUCTS TISSUE CONDITIONER & TEMPORARY RELINER by American Dental Products, Inc. — Product Code EBI

K954637 is an FDA 510(k) premarket notification submitted by American Dental Products, Inc. for the device "AMERICAN DENTAL PRODUCTS TISSUE CONDITIONER & TEMPORARY RELINER". The FDA issued a decision of Substantially Equivalent on December 28, 1995. The device falls under product code EBI (Resin, Denture, Relining, Repairing, Rebasing), a Class II device regulated under 21 CFR 872.3760. American Dental Products, Inc. has at least 10 other 510(k) clearances on record.