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D2 Appliance - Orthodontic appliance system - ARTG 364092

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 registered under ARTG number 364092 and sponsored by Henry Schein Halas, 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.

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Class IIa
ARTG 364092
Class IIa
D2 Appliance - Orthodontic appliance system
ARTG ID: 364092
Good Name: Henry Schein Halas - D2 Appliance - Orthodontic appliance system
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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.

Device Classification
Risk Class
Class IIa
Product Type
Medical device system
ARTG Category
General
Registration Information
ARTG ID
364092
Start Date
May 03, 2021
Effective Date
May 03, 2021
Manufacturer
Country
United States of America
Address
1107 Tower Road, Schaumburg, Illinois, 60173