Dental chair, electric

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

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Available from:
Osstem Australia Pty Ltd
Class:
Class 1
Authorization status:
Included
Authorization number:
322793

Public Summary

Summary for ARTG Entry:

322793

Osstem Australia Pty Ltd - Dental chair, electric

ARTG entry for

Medical Device Included Class 1

Sponsor

Osstem Australia Pty Ltd

Postal Address

6A/5 Talavera Road,Macquarie Park, NSW, 2113

Australia

ARTG Start Date

6/09/2019

Product category

Medical Device Class 1

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

Osstem Implant Co Ltd Chair Business

1st floor B-dong 135 Gasan digital 2-ro

Geumcheon-gu, Seoul, 08504

Korea - Republic of

Products

1. Dental chair, electric

Product Type

Single Device Product

Effective date

6/09/2019

GMDN

47144 Dental chair, electric

Intended purpose

Supports the patient's body during treatment and allows selection of the treatment position. Provides

convenience in using instruments (Hand-piece, Scaler, Suction, etc) during treatment. Intended for use on

humans in the field of dentistry and may only be used by trained dental professionals.

Specific Conditions

© 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 02.11.2019 at 04:50:36 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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