
Pac-Dent International, Inc.
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Pac-Dent Barrier Sleeve, Cover-It(TM) Barrier Film is an FDA 510(k)-cleared medical device (K151123) manufactured by Pac-Dent International, Inc.. This device is classified under the General, Plastic Surgery specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on March 2, 2016. Regulation: 8.