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Allesee Orthodontic Appliances
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FS ALIGNER is an FDA 510(k)-cleared medical device (K093821) 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 August 26, 2010. Regulation: 8.