Device Dossier

Dental prosthesis fabrication material, combination-material

Device Dossier for Dental prosthesis fabrication material, combination-material (Dental prosthesis fabrication material, combination-material, Class IIa,…

Intended purpose

This medical device is made of combinations of carbon and polymer and manufactured ready-to-use condition after fabrication. It is designed to be used for crown, bridge, inlay, onlay, full arch, denture on natural teeth or dental implant for permanent or long term use instructed by dental and medical professionals with computer aided manufacturing (CAD/CAM) technology. Fabricated restorations would be modified and adjusted after setting and cannot be reused.

TGA Public Summary