
Pac-Dent, Inc.
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iMask Disposable Surgical Face Mask is an FDA 510(k)-cleared medical device (K201182) manufactured by Pac-Dent, 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 February 18, 2021. Regulation: 8.