
Sagemax Bioceramics, Inc.
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NEXXZR(TM)T AND NEXXZR(TM)S is an FDA 510(k)-cleared medical device (K130991) manufactured by Sagemax Bioceramics, Inc.. This device is classified under the Dental specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on February 9, 2014. Regulation: 8.