Orthodontic

Main information

  • Trade name:
  • Orthodontic bracket, ceramic
  • Class:
  • Class IIa
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Orthodontic bracket, ceramic
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 221256
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

221256

3M Australia Pty Ltd - Orthodontic bracket, ceramic

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

14/03/2014

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 bracket, ceramic

Product Type

Medical device system

Effective date

14/03/2014

GMDN

58937 Orthodontic bracket, ceramic

Intended purpose

Unitek Ceramic Brackets: Intended for use in orthodontic treatment. The brackets are affixed to teeth so

that pressure can be exerted on the 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 01:37:19 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