
Eastman Kodak Company
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KODAK X-OMAT CASSETTE/LEADLESS FOR DENTAL USE is an FDA 510(k)-cleared medical device (K021903) manufactured by Eastman Kodak Company. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on July 9, 2002. Regulation: 8.