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File, endodontic, hand-held

Access comprehensive regulatory information for File, endodontic, hand-held in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class I is sponsored by Dentavision Pty Ltd, manufactured by Micro Mega SA in France. The device registration started on November 03, 2023.

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
Class I
File, endodontic, hand-held
Australia TGA ARTG Registered Device
Good Name: Dentavision Pty Ltd - File, endodontic, hand-held
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Intended Purpose

The medical devices (K-Files, Hedstroem Files, K-Reamers) are used for catheterisation (nยฐ006 to 015) and root canal shaping (all other diameters) during a non-surgical endodontic treatment. K-Files 008 and 010 are also used in the exploration, initial penetration and root canal permeabilisation.

Device Classification
Risk Class
Class I
Product Type
Single Device Product
ARTG Category
General
Registration Information
Start Date
November 03, 2023
Effective Date
November 03, 2023
Manufacturer
Country
France
Address
12 rue du Tunnel, Besancon, France, 25000