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 light-curable polymerizable resin intended to be used for the fabrication of; individual and fixed definitive full single crowns; definitive partial crowns in anterior and posterior area, individual and fixed single veneers; artificial teeth for dental prostheses, which are used for removable definitive full dentures; and individual and removable monolithic full and partial dentures in dental offices and laboratories. The material is an alternative to traditional restorative dental material. The device is a light-curable resin indicated for the fabrication of individual and fixed temporary full single crowns, temporary partial crowns, and temporary bridges. The material is an alternative to traditional restorative dental material.

TGA Public Summary