ALPHA-DENT CORE BUILDUP PASTE

ALPHA-DENT CORE BUILDUP PASTE is an FDA 510(k)-cleared medical device (K932827) 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 September 22, 1993. Regulation: 8.