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Allesee Orthodontic Appliances
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RED, WHITE & BLUE is an FDA 510(k)-cleared medical device (K040874) manufactured by Allesee Orthodontic Appliances. 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 17, 2004. Regulation: 8.