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Orthodontic appliance, spring - ARTG 404858

Access comprehensive regulatory information for Orthodontic appliance, spring in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is registered under ARTG number 404858 and sponsored by Main Dental Pty Ltd, manufactured by Ortho Solutions LC dba Dynaflex in United States of America. The device registration started on February 14, 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.

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Class IIa
ARTG 404858
Class IIa
Orthodontic appliance, spring
ARTG ID: 404858
Good Name: Main Dental Pty Ltd - Orthodontic appliance, spring
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Intended Purpose

This is a dental device in the shape of a coil intended to be placed around an archwire, a rod, in a bracket, on hooks, pins, screws and/or between teeth, to apply force (e.g., rotational, uprighting, horizontal) as part of an orthodontic force-producing appliance system. This is a single-patient device that is used for the duration of the treatment (single-use) before being discarded.

Device Classification
Risk Class
Class IIa
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
404858
Start Date
February 14, 2023
Effective Date
February 14, 2023
Manufacturer
Country
United States of America
Address
10403 International Plaza Drive, St Ann, Missouri, 63074