Australia TGA ARTG record

Denture base resin, cured

Australia TGA ARTG Registered Device · Australian Imaging · Sprintray Inc · Class I · Started September 13, 2022

Good Name: Australian Imaging - Denture base resin, cured

Device classification

Risk Class: Class I
Product Type: Single Device Product
ARTG Category: General

Registration information

Start Date: September 13, 2022
Effective Date: September 13, 2022

Sponsor

Name: Australian Imaging

Manufacturer

Name: Sprintray Inc
Country: United States of America
Address: 2705 Media Center Dr, Los Angeles, CA, 90065

Intended purpose

The dental resin is a light-curable polymerizable resin intended to be used with external oral curing light equipment. The dental resin is indicated for the fabrication, by additive manufacturing, of: • Night guards • Occlusal guards • Occlusal splints • Temporary crowns • Surgical guides Fabrication of dental applications with dental resin requires a 3D design of the custom device designed by a qualified provider. It also requires a 3D Printer and Cure System to produce the devices. Products manufactured with dental resin are intended for use only up to 30 days in the oral cavity.

About this record

Access comprehensive regulatory information for Denture base resin, cured in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class I is sponsored by Australian Imaging, manufactured by Sprintray Inc in United States of America. The device registration started on September 13, 2022.

This page provides complete registration details including sponsor information, manufacturer details, and regulatory compliance data from the official Australia TGA ARTG medical device database. Pure Global AI offers free access to Australia's complete medical device registry with 131,000+ devices, helping global MedTech companies navigate TGA regulations efficiently.