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Palate-lifting antisnoring orthosis - ARTG 455369

Access comprehensive regulatory information for Palate-lifting antisnoring orthosis in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class I is registered under ARTG number 455369 and sponsored by The Weringa Group Pty Ltd, manufactured by Vivos Therapeutics Inc in United States of America. The device registration started on July 15, 2024.

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
ARTG 455369
Class I
Palate-lifting antisnoring orthosis
ARTG ID: 455369
Good Name: The Weringa Group Pty Ltd - Palate-lifting antisnoring orthosis
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Intended Purpose

Intended to reposition teeth, straighten teeth and expand the jaw, reduce nighttime snoring, obstructive sleep apnea and/or symptoms of sleep-disordered breathing in adults and children. Also designed to limit oral breathing to encourage children to breathe properly through the nose.

Device Classification
Risk Class
Class I
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
455369
Start Date
July 15, 2024
Effective Date
July 15, 2024
Manufacturer
Country
United States of America
Address
300 S 5th Street, Murray, KY, 42071