Device Dossier

CAD/CAM software

Device Dossier for CAD/CAM software (CAD/CAM software, Class IIa, sponsor Emergo). ARTG record, intended purpose, GMDN category — compiled by arcimedes.

Intended purpose

It is intended for use as a medical front-end device providing tools for the management of orthodontic cases, systematic inspection, detailed analysis, treatment simulation, and treatment plan design. It can also be applied during the treatment to inspect and analyze the progress of the treatment. It can be used at the end of the treatment to evaluate if the outcome is consistent with the planned/desired treatment objectives. It can provide training services to promote personal treatment.

TGA Public Summary