Australia - English - Department of Health (Therapeutic Goods Administration)
Summary for ARTG Entry:
Osstem Australia Pty Ltd - Bone particle collector, dental
ARTG entry for
Medical Device Included Class 1
Osstem Australia Pty Ltd
Suite 3 Level 1 Waterloo Business Park 35-41 Waterloo Road,NORTH RYDE, NSW, 2113
ARTG Start Date
Medical Device Class 1
- 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.
Osung Mnd Co Ltd
57 Hwanggeum-ro 109beon-gil Yangchon-eup
, Gyeonggi-do, 415-843
Korea - Republic of
1. Bone particle collector, dental
Single Device Product
44888 Bone particle collector, dental
A small container used as a bone-harvesting device (bone trap) to collect autologous bone fragments,
e.g., when drilling in the jawbone during a dental implant surgical procedure. It functions as a filter that
traps the bone particles and is typically placed in a suction tube line between the site of operation and the
suction unit. The harvested bone particles may be saved for possible future use. This is a single use
No Specific Conditions included on Record
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Produced at 03.11.2017 at 10:19:05 AEDT
This is not an ARTG Certificate document.
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