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File, endodontic, hand-held - ARTG 469267

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 469267 and sponsored by Acteon Australia/New Zealand, manufactured by FKG Dentaire Sarl in Switzerland. The device registration started on November 19, 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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TGA ARTG Official Data
Class Is
ARTG 469267
Class Is
File, endodontic, hand-held
ARTG ID: 469267
Good Name: Acteon Australia/New Zealand - File, endodontic, hand-held
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Intended Purpose

This is a device that is hand held and intended for endodontic treatment. this hand held instrument is used with a rotary action and designed to debride or enlarge the root canal by a side cutting action.

Device Classification
Risk Class
Class Is
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
469267
Start Date
November 19, 2024
Effective Date
November 19, 2024
Manufacturer
Country
Switzerland
Address
Le Cret-du-Locle 4, 2322 Le Cret-du-Locle