Scaler system handpiece, periodontic, ultrasonic

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

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Numedical Pty Ltd
Class IIa
Authorization status:
Authorization number:

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Public Summary

Summary for ARTG Entry:


Numedical Pty Ltd - Scaler system handpiece, periodontic, ultrasonic

ARTG entry for

Medical Device Included Class IIa


Numedical Pty Ltd

Postal Address

9-13 Hender Avenue,Magil, SA, 5072


ARTG Start Date


Product category

Medical Device Class IIa



Approval area

Medical Devices


- 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.




Guilin Woodpecker Medical Instrument Co Ltd

Information Industrial Park Guilin National

High-Tech Information Park

Guilin, Guangxi, 541004



1. Scaler system handpiece, periodontic, ultrasonic

Product Type

Single Device Product

Effective date



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

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.

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