Australia TGA ARTG record

Dental prosthesis-component adhesive

Australia TGA ARTG Registered Device · Durodent Holdings Pty Ltd · Detax GmbH · Class IIa · Started July 28, 2023

Good Name: Durodent Holdings Pty Ltd - Dental prosthesis-component adhesive

Device classification

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

Registration information

Start Date: July 28, 2023
Effective Date: July 28, 2023

Sponsor

Name: Durodent Holdings Pty Ltd

Manufacturer

Name: Detax GmbH
Country: Germany
Address: Carl-Zeiss-Strass 4, Ettlingen, 76275

Intended purpose

Intended Use: Adhesives for denture relinings Indication: Adhesive optimizes the bond strength between relining material and polymerised acrylics. The chemical bond between acrylic and relining material is established by the adhesives. Patient Target Group: Persons being treated in the context of a dental procedure. Intended Users: Dental Professional / Dentist / Dental Technician

About this record

Access comprehensive regulatory information for Dental prosthesis-component adhesive in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is sponsored by Durodent Holdings Pty Ltd, manufactured by Detax GmbH in Germany. The device registration started on July 28, 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.