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Zimmer Dental, Inc.
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ZIMMER ONE PIECE IMPLANT, 3.7MM AND 4.7MM, MODELS ZOP37S10, 11, 13, 16; ZOP37A10, 11, 13, 16; ZOP47S10, 11, 13, 16; ZOP4 is an FDA 510(k)-cleared medical device (K063523) 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 February 15, 2007. Regulation: 8.