Australia flagARTG 469805

Enlarger, endodontic

ARTG ID: 469805 · Acteon Australia/New Zealand · FKG Dentaire Sarl · Class IIa · Started November 21, 2024

Good Name: Acteon Australia/New Zealand - Enlarger, endodontic

Device classification
Risk Class
Class IIa
Product Type
Single Device Product
ARTG Category
General
Registration information
ARTG ID
469805
Start Date
November 21, 2024
Effective Date
November 21, 2024
Sponsor
Manufacturer
Country
Switzerland
Address
Le Cret-du-Locle 4, 2322 Le Cret-du-Locle
Intended purpose

This is a device that is intended to be used for endodontic treatment. These are Gates, XS-Gates and Peeso instruments that are designed to be used to access the root canal and to enlarge the opening of the coronal portion of the root canal. This is a reusable device.

About this record

Access comprehensive regulatory information for Enlarger, endodontic in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is registered under ARTG number 469805 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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