
Alpha-Dent
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CENTRIX'S ENCORE SOLO LIGHT ACTIVATED RESIN CORE is an FDA 510(k)-cleared medical device (K932828) 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 2, 1994. Regulation: 8.