
Medental Intl.
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MEDENTAL CHEMICAL CURING SEALANT PIT & FISSURE TINTED is an FDA 510(k)-cleared medical device (K973541) manufactured by Medental Intl.. This device is classified under the Dental specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on November 24, 1997. Regulation: 8.