Australia TGA ARTG record

Orthodontic appliance, retainer

Australia TGA ARTG Registered Device · Dr DJ Lee Pty Ltd · SMS OPCO LLC dba Six Months Smiles · Class IIa · Started August 03, 2021

Good Name: Dr DJ Lee Pty Ltd - Orthodontic appliance, retainer

Device classification

Risk Class: Class IIa
Product Type: Single Device Product
ARTG Category: General

Registration information

Start Date: August 03, 2021
Effective Date: August 03, 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

A device to maintain teeth in corrected positions following orthodontic procedures.

About this record

Access comprehensive regulatory information for Orthodontic appliance, retainer 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 03, 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.