510(k) K942596

ALPHA-LOCK OR PRO-LOCK FLUORIDE RELEASING GLASS IONOMER BAND CEMENT by Wallace A. Erickson & Co. — Product Code EMA

K942596 is an FDA 510(k) premarket notification submitted by Wallace A. Erickson & Co. for the device "ALPHA-LOCK OR PRO-LOCK FLUORIDE RELEASING GLASS IONOMER BAND CEMENT". The FDA issued a decision of Substantially Equivalent on Jun 16, 1994. The device falls under product code EMA (Cement, Dental), a Class II device regulated under 21 CFR 872.3275. Wallace A. Erickson & Co. has 31 other 510(k) clearances on record.