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File, endodontic, hand-held - ARTG 433571

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 I is registered under ARTG number 433571 and sponsored by W9 Pty Ltd, manufactured by POLDENT Sp Zoo in Poland. The device registration started on January 12, 2024.

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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Class I
ARTG 433571
Class I
File, endodontic, hand-held
ARTG ID: 433571
Good Name: W9 Pty Ltd - File, endodontic, hand-held
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Intended Purpose

A dental device, the working part of which is designed to enlarge the root canal and smooth its walls by a cutting or abrasive action when moved in a longitudinal direction.

Device Classification
Risk Class
Class I
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
433571
Start Date
January 12, 2024
Effective Date
January 12, 2024
Sponsor
Manufacturer
Country
Poland
Address
ul Dzika 1, Warsaw, PL/00-194