Pure Global

Dental occlusal splint, custom-made

Access comprehensive regulatory information for Dental occlusal splint, custom-made 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.

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TGA ARTG Official Data
Class I
Class I
Dental occlusal splint, custom-made
Australia TGA ARTG Registered Device
Good Name: The Weringa Group Pty Ltd - Dental occlusal splint, custom-made
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Intended Purpose

A personalized-per-patient device designed to alleviate clenching and bruxism associated with mild temporomandibular joint dysfunction, with the goal of relieving symptoms of mild temporomandibular joint dysfunction as diagnosed by a doctor or dentist as well as providing relief from mild headaches and pains associated with mild temporomandibular joint dysfunction and mild migraine/tension headaches.

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
Manufacturer
Country
United States of America
Address
300 S 5th Street, Murray, KY, 42071