Australia TGA ARTG record

File, endodontic, hand-held

Australia TGA ARTG Registered Device · Dentavision Pty Ltd · Micro Mega SA · Class I · Started November 03, 2023

Good Name: Dentavision Pty Ltd - File, endodontic, hand-held

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

Sponsor

Name: Dentavision Pty Ltd

Manufacturer

Name: Micro Mega SA
Country: France
Address: 12 rue du Tunnel, Besancon, France, 25000

Intended purpose

The medical devices (K-Files, Hedstroem Files, K-Reamers) are used for catheterisation (n°006 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.

About this record

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.