Australia TGA ARTG record

Orthodontic archwire

Australia TGA ARTG Registered Device · Main Dental Pty Ltd · Ortho Solutions LC dba Dynaflex · Class IIa · Started January 30, 2023

Good Name: Main Dental Pty Ltd - Orthodontic archwire

Device classification

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

Registration information

Start Date: January 30, 2023
Effective Date: January 30, 2023

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

An orthodontic device in the form of a wire in the shape of an arch that is intended to be used with orthodontic attachments and are affixed to the teeth surfaces in order to cause/guide tooth movement during orthodontic treatment.

About this record

Access comprehensive regulatory information for Orthodontic archwire 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 January 30, 2023.

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.