Australia TGA ARTG record

Patient Tray Kits - Orthodontic appliance positioning tray, preloaded

Australia TGA ARTG Registered Device · Dr DJ Lee Pty Ltd · SMS OPCO LLC dba Six Months Smiles · Class IIa · Started August 05, 2021

Good Name: Dr DJ Lee Pty Ltd - Patient Tray Kits - Orthodontic appliance positioning tray, preloaded

Device classification

Risk Class: Class IIa
Product Type: Medical device system
ARTG Category: General

Registration information

Start Date: August 05, 2021
Effective Date: August 05, 2021

Sponsor

Name: Dr DJ Lee Pty Ltd

Manufacturer

Name: SMS OPCO LLC dba Six Months Smiles
Country: United States of America
Address: 6270 Morning Star Drive Suite 120 The Colony, Texas

Intended purpose

Patient matched set of devices required for orthodontic treatment.

About this record

Access comprehensive regulatory information for Patient Tray Kits - Orthodontic appliance positioning tray, preloaded in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa 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 August 05, 2021.

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.