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Orthodontic appliance, retainer

Access comprehensive regulatory information for Orthodontic appliance, retainer in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class I is sponsored by Smileflex, manufactured by Smileflex in Australia. The device registration started on September 10, 2021.

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 I
Class I
Orthodontic appliance, retainer
Australia TGA ARTG Registered Device
Good Name: Smileflex - Orthodontic appliance, retainer
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Intended Purpose

A patient-matched device used to maintain teeth in corrected positions during the period of functional adaptation following corrective treatment, and to maintain the positions of the teeth and jaws effected by orthodontic procedures. It is typically made of synthetic polymer materials. This is a reusable device.

Device Classification
Risk Class
Class I
Product Type
Single Device Product
ARTG Category
General
Registration Information
Start Date
September 10, 2021
Effective Date
September 10, 2021
Sponsor
Manufacturer
Country
Australia
Address
236/416 St Kilda Road, Melbourne, VIC, 3004