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Ortosim, S.A. DE C.V.
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MORALES PROTRACTION FACEMASK is an FDA 510(k)-cleared medical device (K032392) manufactured by Ortosim, S.A. DE C.V.. This device is classified under the Dental specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on October 21, 2003. Regulation: 8.