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Altatec Biotechnologies N.A., Inc.
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SCREWLINE is an FDA 510(k)-cleared medical device (K022425) manufactured by Altatec Biotechnologies N.A., Inc.. 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 13, 2002. Regulation: 8.