IPS E. MAX PRESS ABUTMENT SOLUTIONS FOR NOBEL BIOCARE

IPS E. MAX PRESS ABUTMENT SOLUTIONS FOR NOBEL BIOCARE is an FDA 510(k)-cleared medical device (K124008) manufactured by Ivoclar Vivadent, Agin. This device is classified under the Dental specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on March 28, 2013. Regulation: 8.