510(k) K041229

MULTIPLE (ADDITION SILICONE IMPRESSION MATERIAL) by Cosmedent, Inc. — Product Code ELW

K041229 is an FDA 510(k) premarket notification submitted by Cosmedent, Inc. for the device "MULTIPLE (ADDITION SILICONE IMPRESSION MATERIAL)". The FDA issued a decision of Substantially Equivalent on June 17, 2004. The device falls under product code ELW (Material, Impression), a Class II device regulated under 21 CFR 872.3660. Cosmedent, Inc. has at least 10 other 510(k) clearances on record.