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CAD/CAM unit, dental, chairside - ARTG 470226

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 registered under ARTG number 470226 and sponsored by Henry Schein Halas, manufactured by Exocad GmbH in Germany. The device registration started on November 25, 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 470226
Class IIa
CAD/CAM unit, dental, chairside
ARTG ID: 470226
Good Name: Henry Schein Halas - CAD/CAM unit, dental, chairside
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Intended Purpose

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. Thus, ChairsideCAD is intended to design dental restorations or bite splints. The AbutmentCAD module is intended 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
ARTG ID
470226
Start Date
November 25, 2024
Effective Date
November 25, 2024
Manufacturer
Country
Germany
Address
Rosa-Parks-Str 2, Darmstadt, 64295