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Huge Dental Material Co., Ltd.
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KAIFENG/CRYSTAL, KAILI, KAIJING, KAIYUE, MAIST AND KAITONG/ROYAL SYNTHETIC POLYMER TEETH is an FDA 510(k)-cleared medical device (K101029) manufactured by Huge Dental Material 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 August 15, 2010. Regulation: 8.