Pure Global

Denture reliner, elastic, long-term

Access comprehensive regulatory information for Denture reliner, elastic, long-term 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 reliner, elastic, long-term
Australia TGA ARTG Registered Device
Good Name: Ivoclar Vivadent Pty Ltd - Denture reliner, elastic, long-term
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Intended Purpose

This is a material that is intended to be used under a denture to be placed in the mouth for long term use as a soft reline material. This relining material consists of polymer-based material and is applied as a coating/lining on the denture base, thus facilitating a new fitting surface to a denture - implying better fit and retention while relining an intraoral removable long-term prosthesis.

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