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

Biocompatible resin materials intended to be used in the dental laboratory to manufacture a patient-worn dental prosthesis or appliance (eg. Full and Partial Denture Base, Denture Teeth, Crowns, Temporary Crowns and Bridges, Long-term Bridges, Orthodontic Bases, Surgical Guides and X-ray Templates for Implant Dentistry, Occlusal Orthos, Splints and Retainers) that either: 1) polymerizes under heat (heat-cured), light (light-cured), and/or after a period of time (self-cured); or 2) can be shaped by a dental mill [e.g., based on computer-aided design/computer-aided manufacturing (CAD/CAM) technology].

TGA Public Summary