Pure Global

Orthodontic appliance, retainer

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 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 03, 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
Class IIa
Orthodontic appliance, retainer
Australia TGA ARTG Registered Device
Good Name: Dr DJ Lee Pty Ltd - Orthodontic appliance, retainer
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Intended Purpose

A device to maintain teeth in corrected positions following orthodontic procedures.

Device Classification
Risk Class
Class IIa
Product Type
Single Device Product
ARTG Category
General
Registration Information
Start Date
August 03, 2021
Effective Date
August 03, 2021
Manufacturer
Country
United States of America
Address
6270 Morning Star Drive Suite 120 The Colony, Texas