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Impression material, dental, silicone

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.

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TGA ARTG Official Data
Class IIa
Class IIa
Impression material, dental, silicone
Australia TGA ARTG Registered Device
Good Name: Kulzer Australia Pty Ltd - Impression material, dental, silicone
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Intended Purpose

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

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
Manufacturer
Country
Germany
Address
Leipziger Strasse 2, Hanau, 63450