Australia TGA ARTG record

Denture base resin, cured

Australia TGA ARTG Registered Device · IMC Medical Australia Pty Ltd · Graphy Inc · Class IIa · Started July 24, 2024

Good Name: IMC Medical Australia Pty Ltd - Denture base resin, cured

Device classification

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

Registration information

Start Date: July 24, 2024
Effective Date: July 24, 2024

Sponsor

Name: IMC Medical Australia Pty Ltd

Manufacturer

Name: Graphy Inc
Country: South Korea
Address: #603 #617 Ace Gasan Forhu 225 Gasan digital 1-ro, Geumcheon-gu, Seoul

Intended purpose

TERA HARZ CLEAR is intended for the correction of dental malocclusion in patients with permanent dentition. The TERA HARZ CLEAR is intended for teeth movement by way of continuous gentle force. TERA HARZ CLEAR is a monomer as a biocompatible material based on Acrylic esters indicated for manufacturing of all types of orthodontic aligner and positioners bases in dental laboratories. Fabrication of these prostheses require a manufacturing of all laser and DLP based 3D printers.

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 IIa is sponsored by IMC Medical Australia Pty Ltd, manufactured by Graphy Inc in South Korea. The device registration started on July 24, 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.