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 to be used for simulation and the planning of medical procedures. The subject devices can be used to assist in the positioning of medical device components and to evaluate their size and delivery. 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 applications. The subject devices should be used in conjunction with other diagnostic tools and expert clinical judgement.

TGA Public Summary