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Patient Tray Kits - Orthodontic appliance positioning tray, preloaded - ARTG 372255

Access comprehensive regulatory information for Patient Tray Kits - Orthodontic appliance positioning tray, preloaded in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is registered under ARTG number 372255 and 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 05, 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.

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TGA ARTG Official Data
Class IIa
ARTG 372255
Class IIa
Patient Tray Kits - Orthodontic appliance positioning tray, preloaded
ARTG ID: 372255
Good Name: Dr DJ Lee Pty Ltd - Patient Tray Kits - 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
ARTG ID
372255
Start Date
August 05, 2021
Effective Date
August 05, 2021
Manufacturer
Country
United States of America
Address
6270 Morning Star Drive Suite 120 The Colony, Texas