Australia flagARTG 413290

Dental power tool motorized handpiece/set, electric

ARTG ID: 413290 · Dentsply Sirona Pty Ltd · Sirona Dental Systems GmbH · Class IIa · Started July 11, 2023

Good Name: Dentsply Sirona Pty Ltd - Dental power tool motorized handpiece/set, electric

Device classification
Risk Class
Class IIa
Product Type
Single Device Product
ARTG Category
General
Registration information
ARTG ID
413290
Start Date
July 11, 2023
Effective Date
July 11, 2023
Sponsor
Manufacturer
Country
Germany
Address
Fabrik Strasse 31, Bensheim, Germany, 64625
Intended purpose

The device is intended for use in dentistry to drive endodontic instruments for the mechanical preparation of the patient’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.

About this record

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 registered under ARTG number 413290 and 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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