Pure Global

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 I is sponsored by Ivoclar Vivadent Pty Ltd, manufactured by Detax GmbH in Germany. The device registration started on November 20, 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.

Free Database
Powered by Pure Global AI
TGA ARTG Official Data
Class I
Class I
Impression material, dental, silicone
Australia TGA ARTG Registered Device
Good Name: Ivoclar Vivadent Pty Ltd - Impression material, dental, silicone
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing
Intended Purpose

An elastomeric, polysiloxane-based material capable of reacting to form a rubber-like substance suitable to reproduce the structure of a patient's teeth and gums, or other oral anatomy, after being placed on an impression tray and inserted into the mouth. This is a single-use device.

Device Classification
Risk Class
Class I
Product Type
Single Device Product
ARTG Category
General
Registration Information
Start Date
November 20, 2023
Effective Date
November 20, 2023
Manufacturer
Country
Germany
Address
Carl-Zeiss-Strass 4, Ettlingen, 76275