Pure Global

Orthodontic appliance system, progressive

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.

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Class I
Class I
Orthodontic appliance system, progressive
Australia TGA ARTG Registered Device
Good Name: Dr DJ Lee Pty Ltd - Orthodontic appliance system, progressive
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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.

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
Manufacturer
Country
United States of America
Address
1501 Randolph Street Suite L6, Carrollton, Texas, 75006