ARTG 392395

Orthodontic appliance system, progressive

ARTG ID: 392395 · byte Au Unit Trust · Straight Smile LLC dba Byte · Class I · Started July 18, 2022

Good Name: byte Au Unit Trust - Orthodontic appliance system, progressive

Device classification

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

Registration information

ARTG ID: 392395
Start Date: July 18, 2022
Effective Date: July 18, 2022

Sponsor

Name: byte Au Unit Trust

Manufacturer

Name: Straight Smile LLC dba Byte
Country: United States of America
Address: 1556 20th St Ste A, Santa Monica, CA, 90404

Intended purpose

Custom-made Orthodontic appliances (aligners) are a series of thin clear plastic removable aligners to be worn in succession and self-changed every few weeks to repositions teeth by way of continuous gentle force. Orthodontic appliances (aligners) are indicated for the treatment of tooth malocclusion (e.g., underbites, overbites, cross bites, open bites, crooked teeth) in patients with permanent dentition (i.e. all second molars). This is a reusable device.

About this record

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 I is registered under ARTG number 392395 and sponsored by byte Au Unit Trust, manufactured by Straight Smile LLC dba Byte in United States of America. The device registration started on July 18, 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.