Australia TGA ARTG record

File, endodontic, hand-held

Australia TGA ARTG Registered Device · W9 Pty Ltd · POLDENT Sp Zoo · Class I · Started January 12, 2024

Good Name: W9 Pty Ltd - File, endodontic, hand-held

Device classification

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

Registration information

Start Date: January 12, 2024
Effective Date: January 12, 2024

Sponsor

Name: W9 Pty Ltd

Manufacturer

Name: POLDENT Sp Zoo
Country: Poland
Address: ul Dzika 1, Warsaw, PL/00-194

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.

About this record

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 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.