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Dental abrasive disk, single-use

Access comprehensive regulatory information for Dental abrasive disk, single-use in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is sponsored by Gulmohar Dental Pty Ltd, manufactured by BUSCH & CO GmbH & Co KG in Germany. The device registration started on September 18, 2020.

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 abrasive disk, single-use
Australia TGA ARTG Registered Device
Good Name: Gulmohar Dental Pty Ltd - Dental abrasive disk, single-use
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Intended Purpose

A dental instrument intended to perform a circular and/or oscillatory motion for polishing and finishing a cavity preparation and/or for cutting or polishing dental restorations (e.g., dentures, fillings, crowns). It consists of a circular flat or slightly conical sheet that may carry or contain an abrasive and designed to be fixed at its centre to a mandrel or lather and/or intended to be used with dental handpieces. This is a single-use device

Device Classification
Risk Class
Class IIa
Product Type
Single Device Product
ARTG Category
General
Registration Information
Start Date
September 18, 2020
Effective Date
September 18, 2020
Manufacturer
Country
Germany
Address
17-27 Unterkaltenbach, Engelskirchen, Engelskirchen, D-51766