Pure Global

Denture base resin, cured - ARTG 435690

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 registered under ARTG number 435690 and sponsored by Emergo Asia Pacific Pty Ltd T/a Emergo Australia, manufactured by Sprintray Inc in United States of America. The device registration started on January 19, 2024.

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.

Free Database
Powered by Pure Global AI
TGA ARTG Official Data
Class I
ARTG 435690
Class I
Denture base resin, cured
ARTG ID: 435690
Good Name: Emergo Asia Pacific Pty Ltd T/a Emergo Australia - Denture base resin, cured
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing
Intended Purpose

The device is a light-curable polymerizable resin intended to be used for the fabrication of dental appliances such as mouthguards and nightguards. This material is an alternative to traditional nightguard/mouthguard material. The device is a light-curable polymerizable resin intended to be used for the fabrication of Indirect Bonding Trays. This material is an alternative to traditional IBT material. The device is a light-curable polymerizable resin intended to be used for fabrication of surgical guides. This material is an alternative to traditional surgical guide material.

Device Classification
Risk Class
Class I
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
435690
Start Date
January 19, 2024
Effective Date
January 19, 2024
Manufacturer
Country
United States of America
Address
2710 Media Center Drive Suite #100A, Los Angeles, California, 90065