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Occlusal splint, dental, <specify> - ARTG 218365

Access comprehensive regulatory information for Occlusal splint, dental, <specify> in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class I is registered under ARTG number 218365 and sponsored by Dental Imagination Pty Ltd, manufactured by Plastyle GmbH in Germany. The device registration started on December 11, 2013.

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 218365
Class I
Occlusal splint, dental, <specify>
ARTG ID: 218365
Good Name: Dental Imagination Pty Ltd - Occlusal splint, dental, <specify>
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Intended Purpose

This is a flexible appliance that is intended to overlay 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 (TMJ) conditions.

Device Classification
Risk Class
Class I
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
218365
Start Date
December 11, 2013
Effective Date
December 11, 2013
Manufacturer
Country
Germany
Address
Lessingstrasse 5, Uttenreuth, 91080