Australia TGA ARTG record

Dental material, root filling, gutta-percha

Australia TGA ARTG Registered Device · Ivoclar Vivadent Pty Ltd · Sure Dent Corporation · Class IIa · Started May 04, 2020

Good Name: Ivoclar Vivadent Pty Ltd - Dental material, root filling, gutta-percha

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

Sponsor

Name: Ivoclar Vivadent Pty Ltd

Manufacturer

Name: Sure Dent Corporation
Country: South Korea
Address: #809 52 Sagimakgol-ro Jungwon-gu, Seongnam-si Gyeonggi-do, 13210

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.

About this record

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.