Pure Global

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 Zirkonzahn Australia Pty Ltd, manufactured by Shining 3D Tech Co Ltd in China. The device registration started on March 20, 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
Class IIa
CAD/CAM unit, dental, chairside
Australia TGA ARTG Registered Device
Good Name: Zirkonzahn Australia Pty Ltd - CAD/CAM unit, dental, chairside
Pure Global
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Intended Purpose

Detection Eye is an intraoral scanner that works with the supplied software programs to perform intraoral scanning directly, as well as digitally acquire and save the 2D/3D colour images of the patient's teeth and gingiva for orthodontic, implant and restoration usage. Detection Eye is an intraoral scanner conceived for use in the dental field. The scanner can be used intraorally on the patient to obtain three-dimensional morphology and colour texture information of soft and hard tissue surfaces such as teeth, gums and mucous membranes, facilitating comfortable data capturing for patients, reducing stress for medical care, and improving efficiency for following processing. The scanner and related software programs are conceived for use in dental clinics, dental hospitals, and dental laboratories. This device is designed and intended for use by persons with professions of dentistry and dental laboratory technology. The device in no way interprets these images nor it provides a medical diagnosis of the patient being examined.

Device Classification
Risk Class
Class IIa
Product Type
Single Device Product
ARTG Category
General
Registration Information
Start Date
March 20, 2024
Effective Date
March 20, 2024
Manufacturer
Country
China
Address
No 1398 Xiangbin Road Wenyan Xiaoshan Zhejiang, Hangzhou, 311258