Device Dossier

Denture base resin, cured

Device Dossier for Denture base resin, cured (Dental appliance fabrication material, resin, Class IIa, sponsor Emergo). ARTG record, intended purpose,…

Intended purpose

The device is a tooth shade ceramic-hybrid resin used for the fabrication of hybrid denture prosthetics, implant-supported denture prosthetics, monolithic full and partial removable dentures, and preformed denture teeth to be used in a denture. The device is a light-curable polymerizable resin intended to be used for the fabrication and repair of full and partial removable dentures and baseplates. This material is an alternative to traditional denture base material. The device is a light-curable polymerizable resin intended to be used to fabricate artificial teeth for full and partial removable dentures. This material is an alternative to traditional denture teeth material. The device is an alternative to traditional thermoplastic material used for the fabrication and repair of partial dentures. It is intended exclusively for professional dental work.

TGA Public Summary