510(k) K093338

SELF ADHESIVE COMPOSITE LUTING CEMENT by Dmg USA, Inc. — Product Code EMA

K093338 is an FDA 510(k) premarket notification submitted by Dmg USA, Inc. for the device "SELF ADHESIVE COMPOSITE LUTING CEMENT". The FDA issued a decision of Substantially Equivalent on February 12, 2010. The device falls under product code EMA (Cement, Dental), a Class II device regulated under 21 CFR 872.3275. Dmg USA, Inc. has at least 10 other 510(k) clearances on record.