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Dental material, root-filling, polymer-based - ARTG 348011

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 registered under ARTG number 348011 and 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.

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TGA ARTG Official Data
Class IIa
ARTG 348011
Class IIa
Dental material, root-filling, polymer-based
ARTG ID: 348011
Good Name: Henry Schein Halas - Dental material, root-filling, polymer-based
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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

Device Classification
Risk Class
Class IIa
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
348011
Start Date
November 11, 2020
Effective Date
November 11, 2020
Manufacturer
Country
South Korea
Address
#809 52 Sagimakgol-ro Jungwon-gu, Seongnam-si Gyeonggi-do, 13210