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Denture reliner sealing agent - ARTG 414490

Access comprehensive regulatory information for Denture reliner sealing agent in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is registered under ARTG number 414490 and sponsored by Durodent Holdings Pty Ltd, manufactured by Detax GmbH in Germany. The device registration started on July 25, 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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Class IIa
ARTG 414490
Class IIa
Denture reliner sealing agent
ARTG ID: 414490
Good Name: Durodent Holdings Pty Ltd - Denture reliner sealing agent
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Intended Purpose

Intended use: Silicone gloss varnish for definitive silicone relinings Indication: Silicone-based gloss varnish for sealing and smoothing of Permaliner, Molloplast B & mollosil relinings Patient Target Group: Persons being treated in the context of a dental procedure. Intended Users: Dental Professional / Dentist / Dental Technician

Device Classification
Risk Class
Class IIa
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
414490
Start Date
July 25, 2023
Effective Date
July 25, 2023
Manufacturer
Country
Germany
Address
Carl-Zeiss-Strass 4, Ettlingen, 76275