ARTG 328048Six Month Smile Aligners - Orthodontic appliance system, progressive
ARTG ID: 328048 · Dr DJ Lee Pty Ltd · SMS OPCO LLC dba Six Months Smiles · Class I · Started December 24, 2019
Good Name: Dr DJ Lee Pty Ltd - Six Month Smile Aligners - Orthodontic appliance system, progressive
- Risk Class
- Class I
- Product Type
- Medical device system
- ARTG Category
- General
- ARTG ID
- 328048
- Start Date
- December 24, 2019
- Effective Date
- December 24, 2019
- Country
- United States of America
- Address
- 6270 Morning Star Drive Suite 120 The Colony, Texas
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 typically custom-made for each patient by, e.g., using computer generated modelling based on an initial impression and a final position determined in consultation with the orthodontist. This device is typically made of a clear hard plastic and is single-use.
Access comprehensive regulatory information for Six Month Smile Aligners - 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 328048 and sponsored by Dr DJ Lee Pty Ltd, manufactured by SMS OPCO LLC dba Six Months Smiles in United States of America. The device registration started on December 24, 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.