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Vertex-Dental B.V.
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VERTEX SELF CURING, VERTEX CASTAVARIA, VERTEX CASTAPRESS is an FDA 510(k)-cleared medical device (K102640) manufactured by Vertex-Dental B.V.. This device is classified under the Dental specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on March 24, 2011. Regulation: 8.