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Crown/bridge material, polymer based - ARTG 456265

Access comprehensive regulatory information for Crown/bridge material, polymer based in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is registered under ARTG number 456265 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 456265
Class IIa
Crown/bridge material, polymer based
ARTG ID: 456265
Good Name: IMC Medical Australia Pty Ltd - Crown/bridge material, polymer based
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Intended Purpose

The TERA HARZ material is used for fabricating dental prosthetic device such as crowns and bridges, and veneer. Fabrication of TERA HARZ requires a computer-aided and manufacturing (CAD/CAM) system that includes the following: intraoral scanner, design software, additive printer, and post-cure unit.

Device Classification
Risk Class
Class IIa
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
456265
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