510(k) K881661

IONOSCEM OR IONOSCELL GLASS IONOMER DENTAL CEMENT by Specialites Septodont — Product Code EMA

K881661 is an FDA 510(k) premarket notification submitted by Specialites Septodont for the device "IONOSCEM OR IONOSCELL GLASS IONOMER DENTAL CEMENT". The FDA issued a decision of Substantially Equivalent on June 7, 1988. The device falls under product code EMA (Cement, Dental), a Class II device regulated under 21 CFR 872.3275. Specialites Septodont has at least 10 other 510(k) clearances on record.