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Medimecca Co., Ltd.
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HERO II DENTAL IMPLANT SYSTEM, UI DENTAL IMPLANT SYSTEM is an FDA 510(k)-cleared medical device (K130221) manufactured by Medimecca Co., Ltd.. This device is classified under the Dental specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on March 20, 2013. Regulation: 8.