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Endodontic broach, serrated, single-use - ARTG 469806

Access comprehensive regulatory information for Endodontic broach, serrated, 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 469806 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 469806
Class IIa
Endodontic broach, serrated, single-use
ARTG ID: 469806
Good Name: Acteon Australia/New Zealand - Endodontic broach, serrated, single-use
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Intended Purpose

This is a device that is intended to be used for endodontic treatment. A hand-held, manual, dental, cutting instrument with a slender, tapered, serrated/barbed tip intended to be used for shaping and enlarging holes in root canal tissue, particularly dentine, or for extirpating pulp.

Device Classification
Risk Class
Class IIa
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
469806
Start Date
November 21, 2024
Effective Date
November 21, 2024
Manufacturer
Country
Switzerland
Address
Le Cret-du-Locle 4, 2322 Le Cret-du-Locle