Australia TGA ARTG record

Orthodontic bracket, ceramic

Australia TGA ARTG Registered Device · Naol Australia Pty Ltd · Ortho Arch Company Inc · Class IIa · Started March 18, 2021

Good Name: Naol Australia Pty Ltd - Orthodontic bracket, ceramic

Device classification

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

Registration information

Start Date: March 18, 2021
Effective Date: March 18, 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

A ceramic device intended to be used in orthodontic appliances to be bonded to a tooth to hold an orthodontic archwire or other wire or serve as an anchor point for elastomeric components used to apply pressure to the tooth in order to alter the position of the tooth.

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 Naol Australia Pty Ltd, manufactured by Ortho Arch Company Inc in United States of America. The device registration started on March 18, 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.