510(k) K033309

PREMIER IMPLANT CEMENT, MODEL 3001450 by Premier Dental Products Co. — Product Code EMA

K033309 is an FDA 510(k) premarket notification submitted by Premier Dental Products Co. for the device "PREMIER IMPLANT CEMENT, MODEL 3001450". The FDA issued a decision of Substantially Equivalent on January 26, 2004. The device falls under product code EMA (Cement, Dental), a Class II device regulated under 21 CFR 872.3275. Premier Dental Products Co. has at least 10 other 510(k) clearances on record.