
Prime Dental Manufacturing, Inc.
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PRIME-DENT CHEMICAL CURE COMPOSITE RESTORATIVE MATERIAL is an FDA 510(k)-cleared medical device (K994224) manufactured by Prime Dental Manufacturing, 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 January 30, 2000. Regulation: 8.