Australia TGA ARTG record

Orthodontic aligner/retainer seater, reusable

Australia TGA ARTG Registered Device · byte Au Unit Trust · Huanghua Promisee Dental Co Ltd · Class I · Started June 21, 2023

Good Name: byte Au Unit Trust - Orthodontic aligner/retainer seater, reusable

Device classification

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

Registration information

Start Date: June 21, 2023
Effective Date: June 21, 2023

Sponsor

Name: byte Au Unit Trust

Manufacturer

Name: Huanghua Promisee Dental Co Ltd
Country: China
Address: Mould Industry Garden Empolder Section, Huanghua, Hebei Province, 061100

Intended purpose

A small cylindrical device intended to aid in positioning and seating an orthodontic progressive aligner or teeth retainer into place. This is a reusable device intended for single-patient use.

About this record

Access comprehensive regulatory information for Orthodontic aligner/retainer seater, reusable in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class I is sponsored by byte Au Unit Trust, manufactured by Huanghua Promisee Dental Co Ltd in China. The device registration started on June 21, 2023.

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.