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CAD/CAM unit, dental, chairside

Access comprehensive regulatory information for CAD/CAM unit, dental, chairside in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is sponsored by XYZ Dental Pty Ltd, manufactured by Exocad GmbH in Germany. The device registration started on August 24, 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
Class IIa
CAD/CAM unit, dental, chairside
Australia TGA ARTG Registered Device
Good Name: XYZ Dental Pty Ltd - CAD/CAM unit, dental, chairside
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Intended Purpose

ChairsideCAD is a software device intended to support the design of dental restorations such as inlays, onlays, crowns, copings, veneers, bridges, pontics, provisionals and bite splints via a 3D CAD tool. The design is based on suitable 3D scans of the patientโ€™s dental anatomy produced by a compatible scanner. The software generates geometrical output of the design for manufacturing on compatible CAM systems. ChairsideCAD is intended to be used by trained professionals in dental practices and is not to be used for any purpose other than the design of dental restorations or bite splints. The AbutmentCAD module is a software device intended to be used by trained professionals in dental practices or dental laboratories for the design of patient specific implant borne prosthetics such as one-piece abutments, two-piece/hybrid abutments, single- or multi-unit screw-retained restorations. The design result is intended to be used by the manufacturer of an endosseous dental implant abutment to create the final device.

Device Classification
Risk Class
Class IIa
Product Type
Single Device Product
ARTG Category
General
Registration Information
Start Date
August 24, 2022
Effective Date
August 24, 2022
Manufacturer
Country
Germany
Address
Landwehrstrasse 54, Darmstadt, 64293