Device Dossier

Dental appliance fabrication material, resin

Device Dossier for Dental appliance fabrication material, resin (Dental appliance fabrication material, resin, Class IIa, sponsor Durodent Holdings).…

Intended purpose

The device is a CAD/CAM PMMA milling disc intended for use in the dental laboratory for the fabrication of patient-specific dental prostheses and restorative components, including denture bases and denture teeth. The material is processed by subtractive manufacturing (milling) to produce the final prosthetic component for patient use.

TGA Public Summary