Australia TGA ARTG record

Occlusal splint, dental

Australia TGA ARTG Registered Device · Amalgadent Dental Pty Ltd · Grind Guard Technologies LLC · Class I · Started September 08, 2021

Good Name: Amalgadent Dental Pty Ltd- Occlusal splint, dental

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

Sponsor

Name: Amalgadent Dental Pty Ltd

Manufacturer

Name: Grind Guard Technologies LLC
Country: United States of America
Address: 4498 Klais Drive, Clarkston, MI, 48348

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.

About this record

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.