Orthodontic inter-arch elastic band

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

Buy It Now

Available from:
Adam Dental Supplies
Class:
Class IIa
Authorization status:
Included
Authorization number:
321844

Public Summary

Summary for ARTG Entry:

321844

Adam Dental Supplies - Orthodontic inter-arch elastic band

ARTG entry for

Medical Device Included Class IIa

Sponsor

Adam Dental Supplies

Postal Address

80/66 Kingsway Parade,GLEN WAVERLEY, VIC, 3150

Australia

ARTG Start Date

16/08/2019

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

Ortho Technology Inc

4614 Pet Lane Suite D-101 Lutz

, FL, 33559

United States Of America

Products

1. Orthodontic inter-arch elastic band

Product Type

Single Device Product

Effective date

16/08/2019

GMDN

62074 Orthodontic inter-arch elastic band

Intended purpose

This range of device when used during an orthodontic treatment helps exert continuous force to adjust bite

and/or jaw position to correct malocclusion.

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 06:48:36 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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