Australia TGA ARTG record

Dental material, root-filling, polymer-based

Australia TGA ARTG Registered Device · Henry Schein Halas · Sure Dent Corporation · Class IIa · Started November 11, 2020

Good Name: Henry Schein Halas - Dental material, root-filling, polymer-based

Device classification

Risk Class: Class IIa
Product Type: Single Device Product
ARTG Category: General

Registration information

Start Date: November 11, 2020
Effective Date: November 11, 2020

Sponsor

Name: Henry Schein Halas

Manufacturer

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

Intended purpose

This medical device range 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, polymer-based in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is sponsored by Henry Schein Halas, manufactured by Sure Dent Corporation in South Korea. The device registration started on November 11, 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.