510(k) K964133

AMERICAN DENTAL PRODUCTS HG 35 DESENSITIZER WITH FLUORIDE by American Dental Products, Inc. — Product Code KLE

K964133 is an FDA 510(k) premarket notification submitted by American Dental Products, Inc. for the device "AMERICAN DENTAL PRODUCTS HG 35 DESENSITIZER WITH FLUORIDE". The FDA issued a decision of Substantially Equivalent on January 9, 1997. The device falls under product code KLE (Agent, Tooth Bonding, Resin), a Class II device regulated under 21 CFR 872.3200. American Dental Products, Inc. has at least 10 other 510(k) clearances on record.