Orthodontic archwire

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

Buy It Now

Available from:
Asia Pacific Dental Pty Ltd
Class:
Class IIa
Authorization status:
Included
Authorization number:
293835

Read the complete document

Public Summary

Summary for ARTG Entry:

293835

Asia Pacific Dental Pty Ltd - Orthodontic archwire

ARTG entry for

Medical Device Included Class IIa

Sponsor

Asia Pacific Dental Pty Ltd

Postal Address

1/40 Maud Street,Maroochydore, QLD, 4558

Australia

ARTG Start Date

14/09/2017

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

DANY BMT Co Ltd

B105 Keumkang Penterium 282 Hakui-ro

Dongan-gu Anyang-si, Gyeonggi-do, 421-810

Korea - Republic of

Products

1. Orthodontic archwire

Product Type

Single Device Product

Effective date

14/09/2017

GMDN

41397 Orthodontic archwire

Intended purpose

This is dental wire in the shape of an arch that is intended to be used with orthodontic attachments

(orthodontic brackets) that are affixed to the crowns/surfaces of two or more teeth in order to cause/guide

tooth movement.

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 03:10:33 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