510(k) K103474

ENA TEMP AND ENAMEL PLUS TEMP (TWO DIFFERENT PROPRIETARY NAMES FOR THE SAME PRODUCT) by Micerium S.P.A. — Product Code EBG

K103474 is an FDA 510(k) premarket notification submitted by Micerium S.P.A. for the device "ENA TEMP AND ENAMEL PLUS TEMP (TWO DIFFERENT PROPRIETARY NAMES FOR THE SAME PRODUCT)". The FDA issued a decision of Substantially Equivalent on Feb 7, 2011. The device falls under product code EBG (Crown And Bridge, Temporary, Resin), a Class II device regulated under 21 CFR 872.3770. Micerium S.P.A. has 5 other 510(k) clearances on record.