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Dental x-ray film holder, single-use - ARTG 377928

Access comprehensive regulatory information for Dental x-ray film holder, single-use in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class I is registered under ARTG number 377928 and sponsored by Dentsply Sirona Pty Ltd, manufactured by Sirona Dental Systems GmbH in Germany. The device registration started on November 15, 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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TGA ARTG Official Data
Class I
ARTG 377928
Class I
Dental x-ray film holder, single-use
ARTG ID: 377928
Good Name: Dentsply Sirona Pty Ltd - Dental x-ray film holder, single-use
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Intended Purpose

Positioning holders are intended for use by dental professionals as a means for placement of an Intraoral x-ray sensor to be correctly and comfortably placed inside the patients mouth for various types of intraoral X-ray image captures.

Device Classification
Risk Class
Class I
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
377928
Start Date
November 15, 2021
Effective Date
November 15, 2021
Manufacturer
Country
Germany
Address
Fabrik Strasse 31, Bensheim, Germany, 64625