Ultrasonic

Main information

  • Trade name:
  • Ultrasonic dental surgical system
  • Class:
  • Class IIa
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Ultrasonic dental surgical system
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 221349
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

221349

EMS Electro Medical Systems Australia Pty Ltd- Ultrasonic dental surgical system

ARTG entry for

Medical Device Included Class IIa

Sponsor

EMS Electro Medical Systems Australia Pty Ltd

Postal Address

PO Box 339,CURRUMBIN WATERS, QLD, 4223

Australia

ARTG Start Date

17/03/2014

Product category

Medical Device Class IIa

Status

Active

Approval area

Medical Devices

Conditions

- 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.

Manufacturers

Name

Address

EMS Electro Medical Systems SA

Chemin De La Vuarpilliere 31

NYON, CH-1260,

Switzerland

Products

1. Ultrasonic dental surgical system

Product Type

Medical device system

Effective date

17/03/2014

GMDN

47010 Ultrasonic dental surgical system

Intended purpose

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)

Specific Conditions

No Specific Conditions included on Record

© Commonwealth of Australia.This work is copyright.You are not permitted to re-transmit, distribute or commercialise the material without obtaining prior

written approval from the Commonwealth.Further details can be found at http://www.tga.gov.au/about/website-copyright.htm.

Public Summary

Page 1 of

Produced at 10.11.2017 at 01:23:57 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.

Visit www.tga.gov.au for contact information