Device Dossier

Dental CAD/CAM system application software

Device Dossier for Dental CAD/CAM system application software (CAD/CAM software, Class IIa, sponsor Materialise). ARTG record, intended purpose, GMDN…

Intended purpose

The subject devices are intended for use as a software interface and imaging segmentation system for the transfer of medical imaging information to an output file. The subject devices are intended to support diagnosis and treatment planning. For this purpose, the subject devices provide visualization, measurement, and design tools. The output can be used for the fabrication of physical replicas using traditional or additive manufacturing methods. The fabricated output can be used for diagnostic purposes in the field of orthopedic, maxillofacial, thoracic, and cardiovascular applications. The subject devices should be used in conjunction with other diagnostic tools and expert clinical judgement.

TGA Public Summary