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Occlusal splint, dental

Access comprehensive regulatory information for Occlusal splint, dental in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class I is sponsored by Amalgadent Dental Pty Ltd, manufactured by Grind Guard Technologies LLC in United States of America. The device registration started on September 08, 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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Class I
Class I
Occlusal splint, dental
Australia TGA ARTG Registered Device
Good Name: Amalgadent Dental Pty Ltd- Occlusal splint, dental
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Intended Purpose

A rigid or flexible appliance that overlays the occlusal surfaces of the teeth. It is used to maintain the position of displaced or movable teeth, to treat clenching and bruxism and their sequelae, and to provide temporary relief from muscle or temporo-mandibular joint pain, e.g. temporo-mandibular dysfunction.

Device Classification
Risk Class
Class I
Product Type
Single Device Product
ARTG Category
General
Registration Information
Start Date
September 08, 2021
Effective Date
September 08, 2021
Manufacturer
Country
United States of America
Address
4498 Klais Drive, Clarkston, MI, 48348