Orthodontic

Main information

  • Trade name:
  • Orthodontic appliance, band
  • Class:
  • Class IIa
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Orthodontic appliance, band
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 217130
  • Last update:
  • 09-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

217130

3M Australia Pty Ltd - Orthodontic appliance, band

ARTG entry for

Medical Device Included Class IIa

Sponsor

3M Australia Pty Ltd

Postal Address

Locked Bag 19,NORTH RYDE BC, NSW, 1670

Australia

ARTG Start Date

12/11/2013

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

3M Unitek

2724 South Peck Road

Monrovia, California, 91016-5097

United States Of America

Products

1. Orthodontic appliance, band

Product Type

Single Device Product

Effective date

12/11/2013

GMDN

38734 Orthodontic appliance, band

Intended purpose

Used to secure orthodontic appliances to teeth

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 10.11.2017 at 03:16:56 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