Australia TGA ARTG record

D2 Appliance - Orthodontic appliance system

Australia TGA ARTG Registered Device · Naol Australia Pty Ltd · Ortho Arch Company Inc · Class IIa · Started May 03, 2021

Good Name: Naol Australia Pty Ltd - D2 Appliance - Orthodontic appliance system

Device classification

Risk Class: Class IIa
Product Type: Medical device system
ARTG Category: General

Registration information

Start Date: May 03, 2021
Effective Date: May 03, 2021

Sponsor

Name: Naol Australia Pty Ltd

Manufacturer

Name: Ortho Arch Company Inc
Country: United States of America
Address: 1107 Tower Road, Schaumburg, Illinois, 60173

Intended purpose

To be used in orthodontic dentistry to influence the shape and/or function of the stomatognathic system. Once applied to the teeth, it is periodically adjusted to effect dental changes / tooth movement as desired by the orthodontist.

About this record

Access comprehensive regulatory information for D2 Appliance - Orthodontic appliance system in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is sponsored by Naol Australia Pty Ltd, manufactured by Ortho Arch Company Inc in United States of America. The device registration started on May 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.