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Isotis NV
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ACCELL CONNEXUS DEMINERALIZED BONE MATRIX PUTTY is an FDA 510(k)-cleared medical device (K060306) manufactured by Isotis NV. 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 26, 2006. Regulation: 8.