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Denture reliner, soft - ARTG 445815

Access comprehensive regulatory information for Denture reliner, soft in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is registered under ARTG number 445815 and sponsored by Alphabond Dental Pty Ltd, manufactured by Detax GmbH in Germany. The device registration started on April 16, 2024.

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
ARTG 445815
Class IIa
Denture reliner, soft
ARTG ID: 445815
Good Name: Alphabond Dental Pty Ltd - Denture reliner, soft
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Intended Purpose

This is a silicone based material with a homogeneous consistency that is elastic and is intended to be used on the base of a removal denture in the mouth to cover the sharp-ridged alveolar processes with a thin tegument. Cushioning of dentures against the mylohyoid line, mental foramen or other prominences of the alveolar ridge such as the retromolar triangle or tubera.

Device Classification
Risk Class
Class IIa
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
445815
Start Date
April 16, 2024
Effective Date
April 16, 2024
Manufacturer
Country
Germany
Address
Carl-Zeiss-Strass 4, Ettlingen, 76275