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Oraltronics Dental Implant Technology GmbH
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BIORESORB MACRO PORE is an FDA 510(k)-cleared medical device (K050260) manufactured by Oraltronics Dental Implant Technology GmbH. This device is classified under the Dental specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on July 14, 2005. Regulation: 8.