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Dental ceramic - ARTG 317450

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 registered under ARTG number 317450 and sponsored by Pacific Dental Specialties Pty Ltd, manufactured by Hass Corp in South Korea. The device registration started on May 10, 2019.

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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Class IIa
ARTG 317450
Class IIa
Dental ceramic
ARTG ID: 317450
Good Name: Pacific Dental Specialties Pty Ltd - Dental ceramic
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Intended Purpose

This is a ingot/zirconia blanks of material that is ceramic-based that is intended to be used for the prefabrication of custom-made dental restorations, such as inlays, artificial teeth, metal-ceramic crowns, or bridges and other devices used in dentistry for a restorative purpose.

Device Classification
Risk Class
Class IIa
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
317450
Start Date
May 10, 2019
Effective Date
May 10, 2019
Manufacturer
Country
South Korea
Address
77-14 Gwahakdanji-ro, Gangneung-si, Gangwon-do