
Ivoclar Vivadent, Inc.
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IPS E.MAX CAD CRYSTALL / CONNECT AND IPS E.MAX CAD CRYSTAL / ADD-ON CONNECT (FOR CAD-ON TECHNIQUE) is an FDA 510(k)-cleared medical device (K103556) manufactured by Ivoclar Vivadent, Inc.. This device is classified under the Dental specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on April 12, 2011. Regulation: 8.