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Spreader, endodontic, hand-held - ARTG 466427

Access comprehensive regulatory information for Spreader, endodontic, hand-held in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class I is registered under ARTG number 466427 and sponsored by Acteon Australia/New Zealand, manufactured by FKG Dentaire Sarl in Switzerland. The device registration started on October 30, 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 I
ARTG 466427
Class I
Spreader, endodontic, hand-held
ARTG ID: 466427
Good Name: Acteon Australia/New Zealand - Spreader, endodontic, hand-held
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Intended Purpose

This is a hand held device that is intended to be used for endodontic treatment. This device has a working part of which is tapered, circular in cross-section and has a pointed tip end, it is designed specifically to compress filing materials in a root canal in a mainly lateral direction.

Device Classification
Risk Class
Class I
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
466427
Start Date
October 30, 2024
Effective Date
October 30, 2024
Manufacturer
Country
Switzerland
Address
Le Cret-du-Locle 4, 2322 Le Cret-du-Locle