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Orthodontic appliance system, progressive - ARTG 398415

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 registered under ARTG number 398415 and sponsored by byte Au Unit Trust, manufactured by Straight Smile LLC dba Byte in United States of America. The device registration started on October 26, 2022.

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 398415
Class IIa
Orthodontic appliance system, progressive
ARTG ID: 398415
Good Name: byte Au Unit Trust - Orthodontic appliance system, progressive
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Intended Purpose

The Orthodontic aligner Kits consists of a series of custom made thin clear plastic removable orthodontic appliances (aligners). The aligners gently move the patients teeth in small increments from their original state to a more optimal, treated state. The aligner kit includes vibration-based device which assists in seating of aligners and facilitate teeth movement during aligner use. The kits also include whitening foam, Storage Case, Nail file, extraction tool, aligner tray seaters, Smile Stretcher.

Device Classification
Risk Class
Class IIa
Product Type
Procedure Pack
ARTG Category
General
Registration Information
ARTG ID
398415
Start Date
October 26, 2022
Effective Date
October 26, 2022
Manufacturer
Country
United States of America
Address
1556 20th St Ste A, Santa Monica, CA, 90404