510(k) K063444

TOTAL ETCH BONDING AGENT by Dmg USA, Inc. — Product Code KLE

K063444 is an FDA 510(k) premarket notification submitted by Dmg USA, Inc. for the device "TOTAL ETCH BONDING AGENT". The FDA issued a decision of Substantially Equivalent on March 20, 2007. The device falls under product code KLE (Agent, Tooth Bonding, Resin), a Class II device regulated under 21 CFR 872.3200. Dmg USA, Inc. has at least 10 other 510(k) clearances on record.