GRANITEC DUAL-CURE CORE BUILD-UP, N'DURANCE DIMER CORE

GRANITEC DUAL-CURE CORE BUILD-UP, N'DURANCE DIMER CORE is an FDA 510(k)-cleared medical device (K101540) manufactured by Novocol Inc. Dba Septodont and Confi-Dental Produc. This device is classified under the Dental specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on October 28, 2010. Regulation: 8.