510(k) K052409

SILGIMIX ALGINATE REPLACEMENT IMPRESSION MATERIAL by Sultan Chemists, Inc. — Product Code ELW

K052409 is an FDA 510(k) premarket notification submitted by Sultan Chemists, Inc. for the device "SILGIMIX ALGINATE REPLACEMENT IMPRESSION MATERIAL". The FDA issued a decision of Substantially Equivalent on October 20, 2005. The device falls under product code ELW (Material, Impression), a Class II device regulated under 21 CFR 872.3660. Sultan Chemists, Inc. has at least 10 other 510(k) clearances on record.