VISIO-GEM ART-SYSTEM

VISIO-GEM ART-SYSTEM is an FDA 510(k)-cleared medical device (K905604) manufactured by Espe GmbH (Us). 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, 1991. Regulation: 8.