
Pulpdent Corporation
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TRIPLE-CURE PASTE/PASTE RESIN-REINFORCED GLASS IONOMER CEMENT is an FDA 510(k)-cleared medical device (K030036) manufactured by Pulpdent Corporation. This device is classified under the Dental specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on March 11, 2003. Regulation: 8.