EACTECH OPTECURE DENTAL AND OPTECURE DENTAL + CCC

EACTECH OPTECURE DENTAL AND OPTECURE DENTAL + CCC is an FDA 510(k)-cleared medical device (K103699) manufactured by Exactech, Inc.. This device is classified under the Dental specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on August 11, 2011. Regulation: 8.