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Pentron Clinical Technologies
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SE EPIPHANY ROOT CANAL SEALANT, MODEL N59SE is an FDA 510(k)-cleared medical device (K060889) manufactured by Pentron Clinical Technologies. This device is classified under the Dental specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on October 26, 2006. Regulation: 8.