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Rasp, endodontic, powered - ARTG 469827

Access comprehensive regulatory information for Rasp, endodontic, powered in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is registered under ARTG number 469827 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 469827
Class IIa
Rasp, endodontic, powered
ARTG ID: 469827
Good Name: Acteon Australia/New Zealand - Rasp, endodontic, powered
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Intended Purpose

This is a device that is intended for endodontic treatment. A dental endpiece designed to be attached to a rotary or reciprocating dental power tool handpiece to debride and enlarge the root canal and smooth its walls by cutting or abrasion. It is made of metal [e.g., stainless steel, nickel-titanium alloy (Nitinol) and its working end has a polygonal cross-section with edges. It may also be referred to as a rotary or engine file, or reamer.

Device Classification
Risk Class
Class IIa
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
469827
Start Date
November 21, 2024
Effective Date
November 21, 2024
Manufacturer
Country
Switzerland
Address
Le Cret-du-Locle 4, 2322 Le Cret-du-Locle