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Dental prosthesis fabrication material, combination-material - ARTG 400911

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 400911 and sponsored by Alphabond Dental Pty Ltd, manufactured by Bredent GmbH & Co KG in Germany. The device registration started on December 12, 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 400911
Class IIa
Dental prosthesis fabrication material, combination-material
ARTG ID: 400911
Good Name: Alphabond Dental Pty Ltd - Dental prosthesis fabrication material, combination-material
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Intended Purpose

This is an ingot of material referred to as mixed Zirconia that is intended to be used in a Milling Machine (CAD/CAM)to mill prosthetic teeth in accordance with a scanned model made by scanning the teeth of a patient. The Luxor Z Zirconia Blocks are available in Vita classical shades ranging from A1-D4 plus bleach white shades. The dentists and/or dental technician select the shade required for the specific patient prior to scanning of the teeth. The Luxor Z blocks are multilayer in colour and result in prosthetic teeth lighter in the incisal region and darker in the cervical neck of the tooth within a particular Vita colour selected. The finished prosthetic teeth are fitted onto the plaster or printed model of the patientโ€™s mouth to check for accuracy and then permanently cemented into the patients mouth by the dentist.โ€

Device Classification
Risk Class
Class IIa
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
400911
Start Date
December 12, 2022
Effective Date
December 12, 2022
Manufacturer
Country
Germany
Address
Weissenhorner strasse 2, Senden, 89250