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Orthodontic bracket, ceramic - ARTG 401514

Access comprehensive regulatory information for Orthodontic bracket, ceramic in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is registered under ARTG number 401514 and sponsored by Main Dental Pty Ltd, manufactured by Ortho Solutions LC dba Dynaflex in United States of America. The device registration started on December 22, 2022.

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 401514
Class IIa
Orthodontic bracket, ceramic
ARTG ID: 401514
Good Name: Main Dental Pty Ltd - Orthodontic bracket, ceramic
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Intended Purpose

This is a precision dental component that is welded or soldered to a band or fixed to a tooth or an appliance to facilitate the application of forces during orthodontic treatment. These devices include brackets, buttons, eyelets, cleats, stops, hooks or sheaths.

Device Classification
Risk Class
Class IIa
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
401514
Start Date
December 22, 2022
Effective Date
December 22, 2022
Manufacturer
Country
United States of America
Address
10403 International Plaza Drive, St Ann, Missouri, 63074