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Prime Dental Manufacturing, Inc.
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PRIME-DENT VISIBLE LIGHT CURE PIT & FISSURE SEALANT is an FDA 510(k)-cleared medical device (K012761) 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 October 31, 2001. Regulation: 8.