Pure Global

Occlusal splint, dental, <specify>

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 sponsored by Andarsyn Pty Ltd, manufactured by Plastyle GmbH in Germany. The device registration started on September 22, 2020.

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
Occlusal splint, dental, <specify>
Australia TGA ARTG Registered Device
Good Name: Andarsyn Pty Ltd - Occlusal splint, dental, <specify>
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Intended Purpose

Flexible appliance used in dentistry intended to improve the occlusion and jaw alignment.

Device Classification
Risk Class
Class I
Product Type
Single Device Product
ARTG Category
General
Registration Information
Start Date
September 22, 2020
Effective Date
September 22, 2020
Sponsor
Manufacturer
Country
Germany
Address
Lessingstrasse 5, Uttenreuth, 91080