ARTG 456166

Orthodontic appliance, retainer

ARTG ID: 456166 · Dr DJ Lee Pty Ltd · Xplora USA LLC dba Six Month Smiles · Class IIa · Started July 24, 2024

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

ARTG ID: 456166
Start Date: July 24, 2024
Effective Date: July 24, 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

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 registered under ARTG number 456166 and 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 24, 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.