510(k) K991974

FUTURA GLASS IONOMER SILVER REINFORCED by Ab Ardent — Product Code EMA

K991974 is an FDA 510(k) premarket notification submitted by Ab Ardent for the device "FUTURA GLASS IONOMER SILVER REINFORCED". The FDA issued a decision of Substantially Equivalent on September 17, 1999. The device falls under product code EMA (Cement, Dental), a Class II device regulated under 21 CFR 872.3275. Ab Ardent has at least 10 other 510(k) clearances on record.