Summary for ARTG Entry:
A-DEC Australia - Ultrasonic dental surgical system
ARTG entry for
Medical Device Included Class IIa
PO Box 7421,ALEXANDRIA, NSW, 2015
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.
W & H Dentalwerk Burmoos GmbH
Burmoos, Burmoos, A-5111
1. Ultrasonic dental surgical system
Medical device system
47010 Ultrasonic dental surgical system
Drive unit with a piezoceramic oscillating system used to mechanically fragment and cut bone or soft
tissue upon contact with a vibrating tip during dental surgery in combination with irrigation. For the
treatment of organic hard and soft tissue in dental surgery, implantology, maxillo-facial surgery,
endodontics and periodontics.
No Specific Conditions included on Record
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Produced at 10.11.2017 at 11:09:13 AEDT
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