ESPE KETAC-CEM RADIOPAQUE

ESPE KETAC-CEM RADIOPAQUE is an FDA 510(k)-cleared medical device (K844846) manufactured by Espe GmbH (Us). This device is classified under the Dental specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on March 24, 1985. Regulation: 8.