
Midwest Orthodontic Mfg.
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ORTHODONTIC BRACES is an FDA 510(k)-cleared medical device (K981433) manufactured by Midwest Orthodontic Mfg.. This device is classified under the Dental specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on June 24, 1998. Regulation: 8.