EzDent-i /E2/Prora View

EzDent-i /E2/Prora View is an FDA 510(k)-cleared medical device (K150747) manufactured by LK Consulting Group USA, Inc.. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on April 1, 2015. Regulation: 8.