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Imtec Corp.
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ENDURE IMPLANT, MODEL 3508,3511,3514,4308,4311,4314 is an FDA 510(k)-cleared medical device (K030243) 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 April 22, 2003. Regulation: 8.