PULPDENT DUAL CURE UNFILLED BONDING RESIN

PULPDENT DUAL CURE UNFILLED BONDING RESIN is an FDA 510(k)-cleared medical device (K945112) manufactured by Pulpdent Corp.. This device is classified under the Dental specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on December 13, 1994. Regulation: 8.