Device Dossier

CAD/CAM unit, dental, laboratory

Device Dossier for CAD/CAM unit, dental, laboratory (CAD/CAM unit, dental, laboratory, Class IIa, sponsor Emergo). ARTG record, intended purpose, GMDN…

Intended purpose

The orthodontic treatment planning software is intended for use as a medical front-end device providing tools for management of orthodontic models, systematic inspection, detailed analysis, treatment simulation and virtual design of a series of dental casts, which may be used for sequential aligner trays or retainers, based on 3D models of the patient’s dentition before the start of an orthodontic treatment. 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.

TGA Public Summary