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Six Month Smile Patient Tray - Orthodontic appliance positioning tray, preloaded

Access comprehensive regulatory information for Six Month Smile Patient Tray - 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 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.

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TGA ARTG Official Data
Class IIa
Class IIa
Six Month Smile Patient Tray - Orthodontic appliance positioning tray, preloaded
Australia TGA ARTG Registered Device
Good Name: Dr DJ Lee Pty Ltd - Six Month Smile Patient Tray - Orthodontic appliance positioning tray, preloaded
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Intended Purpose

Patient matched set of devices required for orthodontic treatment.

Device Classification
Risk Class
Class IIa
Product Type
Medical device system
ARTG Category
General
Registration Information
Start Date
July 24, 2024
Effective Date
July 24, 2024
Manufacturer
Country
United States of America
Address
1501 Randolph Street Suite L6, Carrollton, Texas, 75006