
Imtec Corp.
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ENDURE IMPLANT, MODEL 5108, 5111, 5113, 5114 is an FDA 510(k)-cleared medical device (K072660) 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 December 11, 2007. Regulation: 8.