Disposable Barrier Sleeves and Covers

Disposable Barrier Sleeves and Covers is an FDA 510(k)-cleared medical device (K160232) manufactured by Dentsply 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 June 6, 2016. Regulation: 8.