Australia TGA ARTG record

Orthodontic appliance system, progressive

Australia TGA ARTG Registered Device · Dr DJ Lee Pty Ltd · Xplora USA LLC dba Six Month Smiles · Class I · Started July 04, 2024

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

Device classification

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

Registration information

Start Date: July 04, 2024
Effective Date: July 04, 2024

Sponsor

Name: Dr DJ Lee Pty Ltd

Manufacturer

Name: Xplora USA LLC dba Six Month Smiles
Country: United States of America
Address: 1501 Randolph Street Suite L6, Carrollton, Texas, 75006

Intended purpose

Clear aligners are removable orthodontic devices use to correct dental malocclusion. A progressive device of personalised aligners that are worn in sequence and changed every few weeks to guide teeth into correct alignment.

About this record

Access comprehensive regulatory information for 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 Xplora USA LLC dba Six Month Smiles in United States of America. The device registration started on July 04, 2024.

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.