ICE ZIRKON TRANSLUZENT

ICE ZIRKON TRANSLUZENT is an FDA 510(k)-cleared medical device (K132230) manufactured by Zirkonzahn Srl. This device is classified under the Dental specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on November 4, 2014. Regulation: 8.