Australia TGA ARTG record

Intraoral optical scanning system

Australia TGA ARTG Registered Device · Daronez Pty Ltd T/A Pro Smile Designer ATF The J & R Scollo Family Trust · Sirona Dental Systems GmbH · Class IIa · Started January 10, 2022

Good Name: Daronez Pty Ltd T/A Pro Smile Designer ATF The J & R Scollo Family Trust - Intraoral optical scanning system

Device classification

Risk Class: Class IIa
Product Type: Single Device Product
ARTG Category: General

Registration information

Start Date: January 10, 2022
Effective Date: January 10, 2022

Sponsor

Name: Daronez Pty Ltd T/A Pro Smile Designer ATF The J & R Scollo Family Trust

Manufacturer

Name: Sirona Dental Systems GmbH
Country: Germany
Address: Fabrik Strasse 31, Bensheim, Germany, 64625

Intended purpose

The acquisition unit creates digital impressions for dental purposes. The unit may be operated only by qualified personnel. This unit must not be used for any other purpose.

About this record

Access comprehensive regulatory information for Intraoral optical scanning system in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is sponsored by Daronez Pty Ltd T/A Pro Smile Designer ATF The J & R Scollo Family Trust, manufactured by Sirona Dental Systems GmbH in Germany. The device registration started on January 10, 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.