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Noritake Co., Inc.
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SUPER PORCELAIN EX-3 UNIVERSAL OPAQUE is an FDA 510(k)-cleared medical device (K111107) manufactured by Noritake Co., 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 June 29, 2011. Regulation: 8.