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Dental CAD/CAM system application software - ARTG 457681

Access comprehensive regulatory information for Dental CAD/CAM system application software in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is registered under ARTG number 457681 and sponsored by Dentsply Sirona Pty Ltd, manufactured by Sirona Dental Systems GmbH in Germany. The device registration started on July 30, 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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Class IIa
ARTG 457681
Class IIa
Dental CAD/CAM system application software
ARTG ID: 457681
Good Name: Dentsply Sirona Pty Ltd - Dental CAD/CAM system application software
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Intended Purpose

The CAD/CAM software is used to create optical impressions of teeth, jaw situations or models. Based on the optical impressions, digital models and designs are created in the CAD/CAM software and can be exported for preparation from dental materials. The CAD/CAM software allows for digital transmission of optical impressions to dental laboratories or central production services that create dental products.

Device Classification
Risk Class
Class IIa
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
457681
Start Date
July 30, 2024
Effective Date
July 30, 2024
Manufacturer
Country
Germany
Address
Fabrik Strasse 31, Bensheim, Germany, 64625