
Dentsply Intl., Inc.
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VISTADENT OC - VERSION 4 is an FDA 510(k)-cleared medical device (K060836) manufactured by Dentsply Intl., Inc.. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on October 26, 2006. Regulation: 8.