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Alpha-Bio Tec , Ltd.
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ALPHA-BIO ORTHODONTIC FIXATION SCREW SYSTEM is an FDA 510(k)-cleared medical device (K063770) manufactured by Alpha-Bio Tec , Ltd.. This device is classified under the Dental specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on March 25, 2007. Regulation: 8.