HARVEST DENTAL POLYMER BLOCKS (ZCAD, AURORA)

HARVEST DENTAL POLYMER BLOCKS (ZCAD, AURORA) is an FDA 510(k)-cleared medical device (K132937) manufactured by Harvest Dental Products, LLC. This device is classified under the Dental specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on May 20, 2014. Regulation: 8.