DIRECT BONDED BRACKET REMOVER

DIRECT BONDED BRACKET REMOVER is an FDA 510(k)-cleared medical device (K832301) manufactured by Northwest Orthopedics. 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 August 30, 1983. Regulation: 8.