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Dental power tool motorized handpiece/set, electric

Access comprehensive regulatory information for Dental power tool motorized handpiece/set, electric in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is sponsored by Dentsply Sirona Pty Ltd, manufactured by Sirona Dental Systems GmbH in Germany. The device registration started on July 11, 2023.

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 IIa
Class IIa
Dental power tool motorized handpiece/set, electric
Australia TGA ARTG Registered Device
Good Name: Dentsply Sirona Pty Ltd - Dental power tool motorized handpiece/set, electric
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Intended Purpose

The device is intended for use in dentistry to drive endodontic instruments for the mechanical preparation of the patientโ€™s root canal and cavity. Some models incorporate an electronic apex locator that assists the operator to locate the file tip inside the root canal.

Device Classification
Risk Class
Class IIa
Product Type
Single Device Product
ARTG Category
General
Registration Information
Start Date
July 11, 2023
Effective Date
July 11, 2023
Manufacturer
Country
Germany
Address
Fabrik Strasse 31, Bensheim, Germany, 64625