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Neoortho Produtos Ortopedicos S/A
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MINI AND MICRO FRAGMENTS RECONSTRUCTION SYSTEM-NEOFACE is an FDA 510(k)-cleared medical device (K102641) manufactured by Neoortho Produtos Ortopedicos S/A. 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 19, 2010. Regulation: 8.