
Procera Sandvik, Inc.
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Y-TZP POWDER AND PROCERA ALLZIRKON is an FDA 510(k)-cleared medical device (K010630) manufactured by Procera Sandvik, 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 April 16, 2001. Regulation: 8.