Australia TGA ARTG record

Orthodontic bracket, ceramic

Australia TGA ARTG Registered Device · Main Dental Pty Ltd · Ortho Solutions LC dba Dynaflex · Class IIa · Started December 22, 2022

Good Name: Main Dental Pty Ltd - Orthodontic bracket, ceramic

Device classification

Risk Class: Class IIa
Product Type: Single Device Product
ARTG Category: General

Registration information

Start Date: December 22, 2022
Effective Date: December 22, 2022

Sponsor

Name: Main Dental Pty Ltd

Manufacturer

Name: Ortho Solutions LC dba Dynaflex
Country: United States of America
Address: 10403 International Plaza Drive, St Ann, Missouri, 63074

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.

About this record

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 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.