510(k) K942767

ALPHA-DENT C-R(R) HYBRID TYPE II COMPOSITE RESIN by Wallace A. Erickson & Co. — Product Code EBF

K942767 is an FDA 510(k) premarket notification submitted by Wallace A. Erickson & Co. for the device "ALPHA-DENT C-R(R) HYBRID TYPE II COMPOSITE RESIN". The FDA issued a decision of Substantially Equivalent on July 8, 1994. The device falls under product code EBF (Material, Tooth Shade, Resin), a Class II device regulated under 21 CFR 872.3690. Wallace A. Erickson & Co. has at least 10 other 510(k) clearances on record.