
Rizhao Huge Dental Industry Co., Ltd.
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ELASTIC IMPRESSION MATERIAL is an FDA 510(k)-cleared medical device (K133071) manufactured by Rizhao Huge Dental Industry 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 May 27, 2014. Regulation: 8.