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Orthodontic appliance system, progressive

Access comprehensive regulatory information for Orthodontic appliance system, progressive in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is sponsored by Henry Schein Halas, manufactured by Ortho Organizers Inc in United States of America. The device registration started on July 17, 2020.

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
Class IIa
Orthodontic appliance system, progressive
Australia TGA ARTG Registered Device
Good Name: Henry Schein Halas - Orthodontic appliance system, progressive
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Intended Purpose

These single use retainers are a series of clear, lightweight, plastic appliances indicated for the correction of dental malocclusions in patients with permanent dentition. (i.e. all second molars). Hence, in essence, this progressive device is specifically designed/intended to influence the shape and/or function of the stomatognathic system by using a series of preformed teeth aligners/positioners, each worn in succession and changed every few weeks.

Device Classification
Risk Class
Class IIa
Product Type
Single Device Product
ARTG Category
General
Registration Information
Start Date
July 17, 2020
Effective Date
July 17, 2020
Manufacturer
Country
United States of America
Address
1822 Aston Avenue, Carlsbad, CA, 92008-7306