
Pulpdent Corp.
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PULPDENT UNFILLED DUAL CURE BONDING RESIN is an FDA 510(k)-cleared medical device (K930989) 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 April 19, 1993. Regulation: 8.