
Ivoclar Vivadent, AG
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TELIO CS CEM IMPLANT is an FDA 510(k)-cleared medical device (K120432) manufactured by Ivoclar Vivadent, AG. This device is classified under the Dental specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on June 7, 2012. Regulation: 8.