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Denture base resin, cured

Access comprehensive regulatory information for Denture base resin, cured in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is sponsored by Ivoclar Vivadent Pty Ltd, manufactured by Detax GmbH in Germany. The device registration started on December 07, 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 IIa
Class IIa
Denture base resin, cured
Australia TGA ARTG Registered Device
Good Name: Ivoclar Vivadent Pty Ltd - Denture base resin, cured
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Intended Purpose

Light-curing biocompatible resin for the 3D printing of patient-worn dental prostheses or appliances such us denture bases, temporary and permanent crowns and bridges, occlusal splints/night guards, orthodontic apparatus, surgical guides for implant dentistry, fixation, and transfer keys. It may, in addition, be intended to fabricate non-patient-worn devices. This is a single-use device; this material cannot be refabricated after application.

Device Classification
Risk Class
Class IIa
Product Type
Single Device Product
ARTG Category
General
Registration Information
Start Date
December 07, 2023
Effective Date
December 07, 2023
Manufacturer
Country
Germany
Address
Carl-Zeiss-Strass 4, Ettlingen, 76275