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Neobiotech Co., Ltd.
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NEO TITANIUM MESH, CTI-MEM is an FDA 510(k)-cleared medical device (K111761) manufactured by Neobiotech 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 January 9, 2012. Regulation: 8.