Scaler system handpiece, periodontic, ultrasonic

Australia - English - Department of Health (Therapeutic Goods Administration)

Buy It Now

Available from:
Numedical Pty Ltd
Class:
Class IIa
Authorization status:
Included
Authorization number:
293069

Read the complete document

Public Summary

Summary for ARTG Entry:

293069

Numedical Pty Ltd - Scaler system handpiece, periodontic, ultrasonic

ARTG entry for

Medical Device Included Class IIa

Sponsor

Numedical Pty Ltd

Postal Address

9-13 Hender Avenue,Magil, SA, 5072

Australia

ARTG Start Date

22/08/2017

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

Guilin Woodpecker Medical Instrument Co Ltd

Information Industrial Park Guilin National

High-Tech Information Park

Guilin, Guangxi, 541004

China

Products

1. Scaler system handpiece, periodontic, ultrasonic

Product Type

Single Device Product

Effective date

22/08/2017

GMDN

44907 Scaler system handpiece, periodontic, ultrasonic

Intended purpose

Ultrasonic dental scaling/debridement system handpiece; A hand-held component of an ultrasonic dental

debridement system intended to convert high frequency electrical current from a generator into an

ultrasonic oscillation, for a tip placed at its end to mechanically fragment and dislodge gross

debris/accretions during an endodontic and/or periodontal procedure. It may also serve as a conduit for

fluid intended to prevent overheating of the tip and surrounding tissue. This device is typically in the form

of a pen/pencil with attached cables. This is a reusable device.

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 03.11.2017 at 05:58:37 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

Search alerts related to this product

Share this information