
Dentsply Intl.
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MODIFIED PRISMA SHIELD PIT & FISSURE SEALANT is an FDA 510(k)-cleared medical device (K874944) 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 February 7, 1988. Regulation: 8.