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Power tool torque control unit - ARTG 318268

Access comprehensive regulatory information for Power tool torque control unit in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is registered under ARTG number 318268 and sponsored by Osstem Australia Pty Ltd, manufactured by MICRO-NX Co Ltd in South Korea. The device registration started on June 03, 2019.

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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Class IIa
ARTG 318268
Class IIa
Power tool torque control unit
ARTG ID: 318268
Good Name: Osstem Australia Pty Ltd - Power tool torque control unit
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Intended Purpose

This product is a cordless motor handpiece system intended for tightening and loosening an abutment screw to fix and remove the abutment on a dental implant in prosthetic treatment.

Device Classification
Risk Class
Class IIa
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
318268
Start Date
June 03, 2019
Effective Date
June 03, 2019
Manufacturer
Country
South Korea
Address
22 Maeyeo-ro 1gil Dong-gu, Daegu, 41059