Australia TGA ARTG recordCAD/CAM unit, dental, chairside
Australia TGA ARTG Registered Device · Zirkonzahn Australia Pty Ltd · Shining 3D Tech Co Ltd · Class IIa · Started March 20, 2024
Good Name: Zirkonzahn Australia Pty Ltd - CAD/CAM unit, dental, chairside
- Risk Class
- Class IIa
- Product Type
- Single Device Product
- ARTG Category
- General
- Start Date
- March 20, 2024
- Effective Date
- March 20, 2024
- Country
- China
- Address
- No 1398 Xiangbin Road Wenyan Xiaoshan Zhejiang, Hangzhou, 311258
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.
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.