REMOVABLE HERBST APPLIANCE

REMOVABLE HERBST APPLIANCE is an FDA 510(k)-cleared medical device (K955822) manufactured by Univ. Dental Assoc. Department of Orthodontics. This device is classified under the Dental specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on March 19, 1996. Regulation: 8.