IPS 99 ONE AND IPS 99 CERAM

IPS 99 ONE AND IPS 99 CERAM is an FDA 510(k)-cleared medical device (K121359) 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 July 26, 2012. Regulation: 8.