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Denture base resin, cured - ARTG 456247

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 registered under ARTG number 456247 and 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.

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TGA ARTG Official Data
Class IIa
ARTG 456247
Class IIa
Denture base resin, cured
ARTG ID: 456247
Good Name: IMC Medical Australia Pty Ltd - Denture base resin, cured
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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.

Device Classification
Risk Class
Class IIa
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
456247
Start Date
July 24, 2024
Effective Date
July 24, 2024
Manufacturer
Country
South Korea
Address
#603 #617 Ace Gasan Forhu 225 Gasan digital 1-ro, Geumcheon-gu, Seoul