Drilling power tool attachment, basic

Australia - English - Department of Health (Therapeutic Goods Administration)

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Available from:
W & H Australasia Pty Ltd
Class:
Class IIa
Authorization status:
Included
Authorization number:
339690

Public Summary

Summary for ARTG Entry:

339690

W & H Australasia Pty Ltd - Drilling power tool attachment, basic

ARTG entry for

Medical Device Included Class IIa

Sponsor

W & H Australasia Pty Ltd

Postal Address

PO Box 240, BELROSE, NSW, 2085

Australia

ARTG Start Date

17/07/2020

Product Category

Medical Device Class IIa

Status

Active

Approval Area

Medical Devices

Conditions

- The inclusion of the kind of device in the ARTG is subject to compliance with all conditions placed or imposed on the ARTG entry. Refer Part 4-5, Division 2

(Conditions) of the Therapeutic Goods Act 1989 and Part 5, Division 5.2 (Conditions) of the Therapeutic Goods (Medical Devices) Regulations 2002 for

relevant information.

- Breaching conditions of the inclusion related to the device of the kind may lead to suspension or cancellation of the ARTG entry; may be a criminal offence;

and civil penalties may apply.

Manufacturers

Name

Address

W & H Dentalwerk Burmoos GmbH

Ignaz-Glaser-Strasse 53

, Burmoos, 5111

Austria

Products

1 . Drilling power tool attachment, basic

Product Type

Single Device Product

Effective Date

17/07/2020

GMDN

43962 Drilling power tool attachment, basic

Intended Purpose

A device designed to connect to a surgical drilling system handpiece or motor [it is locked and held in a collet or quick coupling and

not simply gripped in a drill chuck (Jacobs chuck)] so that the two devices operate as one to perform a drilling function when an

appropriate drill bit is inserted. It may include integral design features, e.g., have an angled head, be cannulated, have an attached

Jacobs chuck, or have an extended body length to better suit a particular activity. It is typically made of high-grade stainless steel

and synthetic materials. The device may be of the micro or macro design. This is a reusable device.

Specific Conditions

No Specific Conditions included on Record

© Commonwealth of Australia. This work is copyright. You are not permitted to re-transmit, distribute or commercialise the material without obtaining prior

written approval from the Commonwealth. Further details can be found at http://www.tga.gov.au/about/website-copyright.htm.

Public Summary

Page 1 of

Produced at 22.07.2020 at 08:49:46 AEST

This is not an ARTG Certificate document.

The onus is on the reader to verify the current accuracy of the information on the document subsequent to the date shown.

Visit www.tga.gov.au for contact information

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