CompleClear Plastic Orthodontic Bracket and Wire Appliance

CompleClear Plastic Orthodontic Bracket and Wire Appliance is an FDA 510(k)-cleared medical device (K150830) manufactured by Oracrew. This device is classified under the Dental specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on August 25, 2016. Regulation: 8.