GRANITEC IONOMER RESIN CEMENT

GRANITEC IONOMER RESIN CEMENT is an FDA 510(k)-cleared medical device (K940546) manufactured by Confi-Dental Products Co.. This device is classified under the Dental specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on April 28, 1994. Regulation: 8.