DEXIS Titanium, KaVo IXS HD (Size 1, Size 2)

DEXIS Titanium, KaVo IXS HD (Size 1, Size 2) is an FDA 510(k)-cleared medical device (K172918) manufactured by Kavo Dental Technologies, LLC. This device is classified under the Dental specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on December 17, 2017. Regulation: 8.