Australia TGA ARTG record

Impression material, dental, silicone

Australia TGA ARTG Registered Device · Kulzer Australia Pty Ltd · Kulzer GmbH · Class IIa · Started March 13, 2024

Good Name: Kulzer Australia Pty Ltd - Impression material, dental, silicone

Device classification

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

Registration information

Start Date: March 13, 2024
Effective Date: March 13, 2024

Sponsor

Name: Kulzer Australia Pty Ltd

Manufacturer

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

Intended purpose

Silicone-based precision condensation curing impression material for impression taking in direct application suitable for patients requiring dental treatment.

About this record

Access comprehensive regulatory information for Impression material, dental, silicone 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 March 13, 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.