510(k) K021903

KODAK X-OMAT CASSETTE/LEADLESS FOR DENTAL USE by Eastman Kodak Company — Product Code IXA

K021903 is an FDA 510(k) premarket notification submitted by Eastman Kodak Company for the device "KODAK X-OMAT CASSETTE/LEADLESS FOR DENTAL USE". The FDA issued a decision of Substantially Equivalent on July 10, 2002. The device falls under product code IXA (Cassette, Radiographic Film), a Class II device regulated under 21 CFR 892.1850. Eastman Kodak Company has at least 10 other 510(k) clearances on record.