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).…
- GMDN category: Dental appliance fabrication material, resin
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].