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File, endodontic, hand-held - ARTG 430809

Access comprehensive regulatory information for File, endodontic, hand-held in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class Is is registered under ARTG number 430809 and sponsored by Ozdent Pty Ltd, manufactured by Shenzhen Superline Technology Co Ltd in China. The device registration started on December 13, 2023.

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 Is
ARTG 430809
Class Is
File, endodontic, hand-held
ARTG ID: 430809
Good Name: Ozdent Pty Ltd - File, endodontic, hand-held
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Intended Purpose

A dental device, used in the preparation of a root canal. The file is designed to enlarge and smooth the root canal through a cutting or abrasive action.

Device Classification
Risk Class
Class Is
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
430809
Start Date
December 13, 2023
Effective Date
December 13, 2023
Sponsor
Manufacturer
Country
China
Address
Room 1206 Building 4 Chongwen Garden Taoyuan Street Nanshan District, Shenzhen, Guangdong, 518055