ARTG 326610EZ Smile - Orthodontic appliance system, progressive
ARTG ID: 326610 · Ez Smile Pty Ltd · Xi'An Henghui Technologies Ltd · Class I · Started November 25, 2019
Good Name: Ez Smile Pty Ltd - EZ Smile - Orthodontic appliance system, progressive
- Risk Class
- Class I
- Product Type
- Medical device system
- ARTG Category
- General
- ARTG ID
- 326610
- Start Date
- November 25, 2019
- Effective Date
- November 25, 2019
- Name
- Ez Smile Pty Ltd
- Country
- China
- Address
- Fu 6 Keji Road HuaKai West 2nd Floor Gaoxin District, City of Xi'An, ShannXi Province
A progressive device designed to influence the shape and/or function of the stomatognathic system by using a series of preformed teeth aligners/positioners, each worn in succession and changed every few weeks. These are custom-made for each patient by using computer generated modelling based on an initial impression taken at home by the patient which is sent in and a final position determined in consultation with an orthodontist online. This device is typically made of a clear hard plastic and is single patient-use. Only for use in minor to moderate straightening cases.
Access comprehensive regulatory information for EZ Smile - Orthodontic appliance system, progressive in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class I is registered under ARTG number 326610 and sponsored by Ez Smile Pty Ltd, manufactured by Xi'An Henghui Technologies Ltd in China. The device registration started on November 25, 2019.
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.