ULTRADENT CARBON MASK - UPI #342

ULTRADENT CARBON MASK - UPI #342 is an FDA 510(k)-cleared medical device (K041047) manufactured by Medspring Group, Incorporated. 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 November 30, 2004. Regulation: 8.