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Xpert unit - Line-powered surgical power tool control unit - ARTG 475980

Access comprehensive regulatory information for Xpert unit - Line-powered surgical power tool 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 475980 and sponsored by Straumann Pty Ltd, manufactured by Anthogyr in France. The device registration started on January 16, 2025.

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 475980
Class IIa
Xpert unit - Line-powered surgical power tool control unit
ARTG ID: 475980
Good Name: Straumann Pty Ltd - Xpert unit - Line-powered surgical power tool control unit
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Intended Purpose

The Xpert Unitยฎ is intended to drive micromotor (not included) and dental handpieces equipped with instruments (not included) to cut hard and soft tissues in the mouth and to insert dental implants, while monitoring tool speed, torque and irrigation supply. Xpert Unitยฎ is intended only for use in the field of dentistry, for implantology and dental surgery. The device also provides an indication of the torque applied in implant placement when used in combination with contra-angle handpieces (not included). An interface (screen or pedal) allows the user to adjust and memorise different settings for the parameters of speed, torque, pump flow, and reduction gear.

Device Classification
Risk Class
Class IIa
Product Type
Medical device system
ARTG Category
General
Registration Information
ARTG ID
475980
Start Date
January 16, 2025
Effective Date
January 16, 2025
Manufacturer
Country
France
Address
2237 Avenue Andre Lasquin, Sallanches, 74700