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Imtec Corp.
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MDI MII ONE-PIECE IMPLANT, 2.9MM is an FDA 510(k)-cleared medical device (K081653) manufactured by Imtec Corp.. This device is classified under the Dental specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on September 18, 2008. Regulation: 8.