
Dentsply Intl.
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DELTON F PIT & FISSURE SEALANT is an FDA 510(k)-cleared medical device (K951296) manufactured by Dentsply 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 May 2, 1995. Regulation: 8.