Australia TGA ARTG record

Adhesive, dental impression

Australia TGA ARTG Registered Device · Kulzer Australia Pty Ltd · Kulzer GmbH · Class IIa · Started January 22, 2024

Good Name: Kulzer Australia Pty Ltd - Adhesive, dental impression

Device classification

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

Registration information

Start Date: January 22, 2024
Effective Date: January 22, 2024

Sponsor

Name: Kulzer Australia Pty Ltd

Manufacturer

Name: Kulzer GmbH
Country: Germany
Address: Leipziger Strasse 2, Hanau, 63450

Intended purpose

Suitable for patients requiring dental treatment for the following indications, Adhesive for use between standard or customised impression trays and silicon impression materials.

About this record

Access comprehensive regulatory information for Adhesive, dental impression in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is sponsored by Kulzer Australia Pty Ltd, manufactured by Kulzer GmbH in Germany. The device registration started on January 22, 2024.

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.