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Dental prosthesis-component adhesive - ARTG 414836

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 registered under ARTG number 414836 and 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.

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Class IIa
ARTG 414836
Class IIa
Dental prosthesis-component adhesive
ARTG ID: 414836
Good Name: Durodent Holdings Pty Ltd - Dental prosthesis-component adhesive
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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

Device Classification
Risk Class
Class IIa
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
414836
Start Date
July 28, 2023
Effective Date
July 28, 2023
Manufacturer
Country
Germany
Address
Carl-Zeiss-Strass 4, Ettlingen, 76275