Pure Global

Spacer, dental

Access comprehensive regulatory information for Spacer, dental in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class I is sponsored by Digital Sleep Devices Pty Ltd, manufactured by Medealis GmbH in Germany. The device registration started on July 26, 2022.

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
Spacer, dental
Australia TGA ARTG Registered Device
Good Name: Digital Sleep Devices Pty Ltd - Spacer, dental
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Intended Purpose

This is a device that is material that is intended to be used to be applied to the surface of edentulous ridges and dental structures before the preliminary application of impression material in the mouth.

Device Classification
Risk Class
Class I
Product Type
Single Device Product
ARTG Category
General
Registration Information
Start Date
July 26, 2022
Effective Date
July 26, 2022
Manufacturer
Country
Germany
Address
Im Steinboehl 9, Abtsteinach, 69518