Plasdent Disposable Barrier Sleeves and Barrier Film

Plasdent Disposable Barrier Sleeves and Barrier Film is an FDA 510(k)-cleared medical device (K201604) manufactured by Plasdent Corporation. 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 December 22, 2020. Regulation: 8.