Australia TGA ARTG record

Bur, dental, diamond

Australia TGA ARTG Registered Device · Medi-Dent Pty Ltd · Dendia GmbH · Class IIa · Started February 02, 2023

Good Name: Medi-Dent Pty Ltd - Bur, dental, diamond

Device classification

Risk Class: Class IIa
Product Type: Single Device Product
ARTG Category: General

Registration information

Start Date: February 02, 2023
Effective Date: February 02, 2023

Sponsor

Name: Medi-Dent Pty Ltd

Manufacturer

Name: Dendia GmbH
Country: Austria
Address: 126 Reichsstrasse, Feldkirch, A-6800

Intended purpose

Diamond coated rotary dental cutting tools used on dental hard materials (enamel), for caries removal (diseased tooth substance) or cavity preparation (to prepare for direct restorations and smoothen them), as well as for widening root canals.

About this record

Access comprehensive regulatory information for Bur, dental, diamond in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is sponsored by Medi-Dent Pty Ltd, manufactured by Dendia GmbH in Austria. The device registration started on February 02, 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.