CENTRIX'S ENCORE COMPOSITE RESIN CORE PASTE W\FLUO

CENTRIX'S ENCORE COMPOSITE RESIN CORE PASTE W\FLUO is an FDA 510(k)-cleared medical device (K932826) 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 January 27, 1994. Regulation: 8.