
Dentsply Intl.
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JELTRATE PLUS ANTIMICROBIAL IMPR. MATERIAL is an FDA 510(k)-cleared medical device (K952614) 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 August 12, 1996. Regulation: 8.