Pure Global

Dental material, root filling, gutta-percha

Access comprehensive regulatory information for Dental material, root filling, gutta-percha in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is sponsored by Ivoclar Vivadent Pty Ltd, manufactured by Sure Dent Corporation in South Korea. The device registration started on May 04, 2020.

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
Class IIa
Dental material, root filling, gutta-percha
Australia TGA ARTG Registered Device
Good Name: Ivoclar Vivadent Pty Ltd - Dental material, root filling, gutta-percha
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Intended Purpose

This is a prefabricated dental substance that is intended to be used to fill or obturate the root canal of teeth during dental endodontic procedures in the mouth.

Device Classification
Risk Class
Class IIa
Product Type
Single Device Product
ARTG Category
General
Registration Information
Start Date
May 04, 2020
Effective Date
May 04, 2020
Manufacturer
Country
South Korea
Address
#809 52 Sagimakgol-ro Jungwon-gu, Seongnam-si Gyeonggi-do, 13210