Scaler system, periodontic, ultrasonic

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

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Available from:
Hayes Handpiece Australia
Class:
Class IIa
Authorization status:
Included
Authorization number:
291487

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Public Summary

Summary for ARTG Entry:

291487

Hayes Handpiece Australia - Scaler system, periodontic, ultrasonic

ARTG entry for

Medical Device Included Class IIa

Sponsor

Hayes Handpiece Australia

Postal Address

31 Hooper Crescent,TEWANTIN, QLD, 4565

Australia

ARTG Start Date

13/07/2017

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

Dmetec Co Ltd

402-601 602 603 Bucheon Techno-Park 655

Pyeongcheon-Ro Wonmi-gu Bucheon-City

, Gyeonggi-do,

Korea - Republic of

Products

1. Scaler system, periodontic, ultrasonic

Product Type

Medical device system

Effective date

13/07/2017

GMDN

36047 Scaler system, periodontic, ultrasonic

Intended purpose

A medical device using ultrasonic energy in a vibrating tip for the removal of accretions from tooth surfaces

during oral prophylaxis and periodontal therapy.

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 12:20:10 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

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