Summary for ARTG Entry:
Nobel Biocare Australia Pty Ltd - Drill/saw system, dental
ARTG entry for
Medical Device Included Class IIa
Nobel Biocare Australia Pty Ltd
PO Box 1065,NORTH RYDE BC, NSW, 1670
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 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.
Bien Air Dental SA
Bienne, , CH-2504
1. Drill/saw system, dental
Medical device system
45572 Drill/saw system, dental
The osseocare system is intended for use in dental surgery, endodontics and implantology. The main unit
is designed to operate a dental micromotor that drives dental handpieces fitted with appropriate tools to
cut hard and soft tissues in the mouth and to screw dental implants.
1. Under this inclusion the system is specifically intended to work together with the Osseocare Pro Console, iPad & Osseocare Pro Software App.
(Control of the system by different electronic devices or software Apps requires a separate application in the ARTG.)
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Produced at 10.11.2017 at 11:32:33 AEDT
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.
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