
Pac-Dent, Inc.
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Pac-Dent Ceramic Nanohybrid Resin is an FDA 510(k)-cleared medical device (K210412) manufactured by Pac-Dent, Inc.. This device is classified under the Dental specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on July 25, 2021. Regulation: 8.