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Line-powered surgical power tool control unit

Access comprehensive regulatory information for 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 sponsored by Biomedent Pty Ltd, manufactured by Bien Air Dental SA in Switzerland. The device registration started on April 24, 2024.

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
Class IIa
Line-powered surgical power tool control unit
Australia TGA ARTG Registered Device
Good Name: Biomedent Pty Ltd - Line-powered surgical power tool control unit
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Intended Purpose

This is an electrical console that is intended to be used used to run dental instruments. This console transfers energy to the corresponding dental micromotor, which then allows to run a dental handpiece, fitted with appropriate tools to cut hard and soft tissues in the oral cavity.

Device Classification
Risk Class
Class IIa
Product Type
Single Device Product
ARTG Category
General
Registration Information
Start Date
April 24, 2024
Effective Date
April 24, 2024
Manufacturer
Country
Switzerland
Address
Langgasse 60, Bienne, CH-2504