COMPOSITE RESTORATIVE MATERIAL/RADIOPAQUE

COMPOSITE RESTORATIVE MATERIAL/RADIOPAQUE is an FDA 510(k)-cleared medical device (K904812) manufactured by Alpha-Dent. This device is classified under the Dental specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on February 25, 1991. Regulation: 8.