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Imtec Corp.
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ENDURE IMPLANT, MODELS 3508, 4308, 3520, 4320 is an FDA 510(k)-cleared medical device (K043226) 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 January 12, 2005. Regulation: 8.