Pure Global

Dental ceramic

Access comprehensive regulatory information for Dental ceramic in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is sponsored by Dental Axess Pty Ltd, manufactured by Hass Corp in South Korea. The device registration started on October 18, 2021.

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 IIa
Class IIa
Dental ceramic
Australia TGA ARTG Registered Device
Good Name: Dental Axess Pty Ltd - Dental ceramic
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing
Intended Purpose

This is an ingot of dental material which has a ceramic-base that is intended to be used in prefabricated and custom-made dental restorations and other prosthetic devices to be used in the mouth during dental restorations such as inlays, artificial teeth, metal-ceramic crowns, or bridges.

Device Classification
Risk Class
Class IIa
Product Type
Single Device Product
ARTG Category
General
Registration Information
Start Date
October 18, 2021
Effective Date
October 18, 2021
Manufacturer
Country
South Korea
Address
77-14 Gwahakdanji-ro, Gangneung-si, Gangwon-do