COMPCORE AF COMPOSITE CORE BUILD-UP MATERIAL, MODEL 3001408

COMPCORE AF COMPOSITE CORE BUILD-UP MATERIAL, MODEL 3001408 is an FDA 510(k)-cleared medical device (K012160) manufactured by Premier Dental Products Co.. This device is classified under the Dental specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on September 26, 2001. Regulation: 8.