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Dio Department Dsi, Inc.
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SM-EXTRA WIDE (RBM) IMPLANT SYSTEM is an FDA 510(k)-cleared medical device (K080128) manufactured by Dio Department Dsi, 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 May 13, 2008. Regulation: 8.