IPS E.MAX CAD ABUTMENT SOLUTIONS

IPS E.MAX CAD ABUTMENT SOLUTIONS is an FDA 510(k)-cleared medical device (K132209) 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 October 30, 2013. Regulation: 8.