Z-BLOCK, MODELS 20/19, 40/19, 55/19

Z-BLOCK, MODELS 20/19, 40/19, 55/19 is an FDA 510(k)-cleared medical device (K062389) manufactured by Foundation Milling Centre. This device is classified under the Dental specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on August 20, 2006. Regulation: 8.