Six Month Smile Aligners - Orthodontic appliance system, progressive
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 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.
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.