Orthodontic inter-arch elastic band

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

Buy It Now

Available from:
American Orthodontics Aust/NZ Pty Ltd
Class:
Class IIa
Authorization status:
Included
Authorization number:
322061

Public Summary

Summary for ARTG Entry:

322061

American Orthodontics Aust/NZ Pty Ltd - Orthodontic inter-arch elastic band

ARTG entry for

Medical Device Included Class IIa

Sponsor

American Orthodontics Aust/NZ Pty Ltd

Postal Address

Suite 101/63 Stead Street,SOUTH MELBOURNE, VIC, 3205

Australia

ARTG Start Date

20/08/2019

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

American Orthodontics Corp

3524 Washington Avenue

Sheboygan, WI, 53081

United States Of America

Products

1. Orthodontic inter-arch elastic band

Product Type

Single Device Product

Effective date

20/08/2019

GMDN

62074 Orthodontic inter-arch elastic band

Intended purpose

A non-sterile circular band intended to be used during orthodontic treatment to exert a

continuous light force to adjust bite and jaw position for correcting malocclusions (e.g.,

overbite, underbite). It is made of an elastomeric material and is secured to hooks on

orthodontic brackets across non-opposing mandibular and maxillary teeth. This is a single patient

device intended to be replaced regularly during orthodontic treatment (single-use).

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 06:27:00 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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