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Manual endodontic file/rasp, single-use - ARTG 469767

Access comprehensive regulatory information for Manual endodontic file/rasp, single-use in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is registered under ARTG number 469767 and sponsored by Acteon Australia/New Zealand, manufactured by FKG Dentaire Sarl in Switzerland. The device registration started on November 21, 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 IIa
ARTG 469767
Class IIa
Manual endodontic file/rasp, single-use
ARTG ID: 469767
Good Name: Acteon Australia/New Zealand - Manual endodontic file/rasp, single-use
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Intended Purpose

This is a device that is intended for endodontic treatment. These Hand-held dental instruments are used with a rotary action and designed to debride or enlarge the root canal by a side cutting action.

Device Classification
Risk Class
Class IIa
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
469767
Start Date
November 21, 2024
Effective Date
November 21, 2024
Manufacturer
Country
Switzerland
Address
Le Cret-du-Locle 4, 2322 Le Cret-du-Locle