Summary for ARTG Entry:
EMS Electro Medical Systems Australia Pty Ltd- Ultrasonic dental surgical system
ARTG entry for
Medical Device Included Class IIa
EMS Electro Medical Systems Australia Pty Ltd
PO Box 339,CURRUMBIN WATERS, QLD, 4223
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.
EMS Electro Medical Systems SA
Chemin De La Vuarpilliere 31
1. Ultrasonic dental surgical system
Medical device system
47010 Ultrasonic dental surgical system
An assembly of devices that converts high frequency current into ultrasonic oscillation to mechanically
fragment and cut bone upon contact with a vibrating tip during dental surgery, typically in combination with
irrigation. It is used for:
Periodontal Surgery (Osteotomy and osteoplasty, extraction of autogenous bone for regenerative surgery)
Implantology (Alveolar ridge splitting, sinus lift, extraction of autogenous bone, implant site preparation)
Oral surgery(Extraction, root resection, syndesmotomy, orthodontic surgery.)
Maxillary surgery (Extraction of bone cylinders, osteogenetic distraction, nerve transposition, sinus
elevation, distraction osteogenesis)
No Specific Conditions included on Record
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Produced at 10.11.2017 at 01:23:57 AEDT
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