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Zimmer Dental, Inc.
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3.25 SPLINE TWIST IMPLANT, HA COATED is an FDA 510(k)-cleared medical device (K093164) manufactured by Zimmer Dental, 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 December 14, 2009. Regulation: 8.