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Impression material, dental, silicone - ARTG 428132

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 registered under ARTG number 428132 and 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.

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TGA ARTG Official Data
Class I
ARTG 428132
Class I
Impression material, dental, silicone
ARTG ID: 428132
Good Name: Ivoclar Vivadent Pty Ltd - Impression material, dental, silicone
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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
ARTG ID
428132
Start Date
November 20, 2023
Effective Date
November 20, 2023
Manufacturer
Country
Germany
Address
Carl-Zeiss-Strass 4, Ettlingen, 76275