Device Dossier

Dental CAD/CAM system application software

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

Intended purpose

The CAD/CAM software is used to create optical impressions of teeth, jaw situations or models. Based on the optical impressions, digital models and designs are created in the CAD/CAM software and can be exported for preparation from dental materials. The CAD/CAM software allows for digital transmission of optical impressions to dental laboratories or central production services that create dental products.

TGA Public Summary