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Adhesive, bracket/tooth conditioner, polymer based - ARTG 339790

Access comprehensive regulatory information for Adhesive, bracket/tooth conditioner, polymer based in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is registered under ARTG number 339790 and sponsored by Emergo Asia Pacific Pty Ltd T/a Emergo Australia, manufactured by Reliance Orthodontic Products Inc in United States of America. The device registration started on July 20, 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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TGA ARTG Official Data
Class IIa
ARTG 339790
Class IIa
Adhesive, bracket/tooth conditioner, polymer based
ARTG ID: 339790
Good Name: Emergo Asia Pacific Pty Ltd T/a Emergo Australia - Adhesive, bracket/tooth conditioner, polymer based
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Intended Purpose

This device is intended for use as a dual cure glass ionomer band cement for use in an orthodontic or dental office. It is used to bond molar bands to an enamel or metal substrate in a wet or dry field due to its hydrophilic properties.

Device Classification
Risk Class
Class IIa
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
339790
Start Date
July 20, 2020
Effective Date
July 20, 2020
Manufacturer
Country
United States of America
Address
1540 West Thorndale Avenue, Itasca, IL, 60143