510(k) K042215

RADIOPAQUE, GLASS IONOMER ENDODONTIC CEMENT by Premier Dental Products Co. — Product Code EMA

K042215 is an FDA 510(k) premarket notification submitted by Premier Dental Products Co. for the device "RADIOPAQUE, GLASS IONOMER ENDODONTIC CEMENT". The FDA issued a decision of Substantially Equivalent on September 21, 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.