510(k) K043054

GENIE MAGIC MIX ULTRA HYDROPHILIC IMPRESSION MATERIAL by Sultan Chemists, Inc. — Product Code ELW

K043054 is an FDA 510(k) premarket notification submitted by Sultan Chemists, Inc. for the device "GENIE MAGIC MIX ULTRA HYDROPHILIC IMPRESSION MATERIAL". The FDA issued a decision of Substantially Equivalent on February 18, 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.