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Dental prosthesis fabrication material, combination-material - ARTG 396785

Access comprehensive regulatory information for Dental prosthesis fabrication material, combination-material in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is registered under ARTG number 396785 and sponsored by Collective Mode Pty Ltd, manufactured by Graphenano Dental SL in Spain. The device registration started on September 30, 2022.

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 396785
Class IIa
Dental prosthesis fabrication material, combination-material
ARTG ID: 396785
Good Name: Collective Mode Pty Ltd - Dental prosthesis fabrication material, combination-material
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Intended Purpose

This medical device is made of combinations of carbon and polymer and manufactured ready-to-use condition after fabrication. It is designed to be used for crown, bridge, inlay, onlay, full arch, denture on natural teeth or dental implant for permanent or long term use instructed by dental and medical professionals with computer aided manufacturing (CAD/CAM) technology. Fabricated restorations would be modified and adjusted after setting and cannot be reused.

Device Classification
Risk Class
Class IIa
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
396785
Start Date
September 30, 2022
Effective Date
September 30, 2022
Manufacturer
Country
Spain
Address
Poligono Industrial Tactica de Paterna Calle 2 Numero 1, Paterna, 46980