Scaler

Main information

  • Trade name:
  • Scaler system, periodontic, ultrasonic
  • Class:
  • Class IIa
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Scaler system, periodontic, ultrasonic
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 221350
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

221350

EMS Electro Medical Systems Australia Pty Ltd- Scaler system, periodontic, ultrasonic

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. Scaler system, periodontic, ultrasonic

Product Type

Medical device system

Effective date

17/03/2014

GMDN

36047 Scaler system, periodontic, ultrasonic

Intended purpose

A collection of devices using ultrasonic energy in a vibrating tip for the removal of accumulations from

tooth surfaces during oral prophylaxis and periodontal therapy. This device is used for oral hygiene and

periodontal debridement such as removal of plaque, biofilm, and gross calculus from shallow to deep

periodontal pockets as well as the removal of orthodontic cement.

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 01:23:41 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