CODIAGNOSTIX IMPLANT PLANNING SOFTWARE

CODIAGNOSTIX IMPLANT PLANNING SOFTWARE is an FDA 510(k)-cleared medical device (K130724) manufactured by Straumann USA. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on June 27, 2013. Regulation: 8.