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Harry J. Bosworth Co.
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PIT & FISSURE SEALANT WITH FLUORIDE is an FDA 510(k)-cleared medical device (K031811) manufactured by Harry J. Bosworth Co.. This device is classified under the Dental specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on September 3, 2003. Regulation: 8.