Australia TGA ARTG record

Palate-lifting antisnoring orthosis

Australia TGA ARTG Registered Device · The Weringa Group Pty Ltd · Vivos Therapeutics Inc · Class I · Started July 15, 2024

Good Name: The Weringa Group Pty Ltd - Palate-lifting antisnoring orthosis

Device classification

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

Registration information

Start Date: July 15, 2024
Effective Date: July 15, 2024

Sponsor

Name: The Weringa Group Pty Ltd

Manufacturer

Name: Vivos Therapeutics Inc
Country: United States of America
Address: 300 S 5th Street, Murray, KY, 42071

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.

About this record

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 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.