Australia - English - Department of Health (Therapeutic Goods Administration)
Summary for ARTG Entry:
W & H Australasia Pty Ltd - Drilling power tool attachment, basic
ARTG entry for
Medical Device Included Class IIa
W & H Australasia Pty Ltd
PO Box 240, BELROSE, NSW, 2085
ARTG Start Date
Medical Device Class IIa
- 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
- 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.
W & H Dentalwerk Burmoos GmbH
, Burmoos, 5111
1 . Drilling power tool attachment, basic
Single Device Product
43962 Drilling power tool attachment, basic
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.
No Specific Conditions included on Record
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Produced at 22.07.2020 at 08:49:46 AEST
This is not an ARTG Certificate document.
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