Orthodontic appliance, retainer

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

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Available from:
Myofunctional Research Co
Class:
Class 1
Authorization status:
Included
Authorization number:
322397

Public Summary

Summary for ARTG Entry:

322397

Myofunctional Research Co - Orthodontic appliance, retainer

ARTG entry for

Medical Device Included Class 1

Sponsor

Myofunctional Research Co

Postal Address

PO Box 14,HELENSVALE, QLD, 4212

Australia

ARTG Start Date

28/08/2019

Product category

Medical Device Class 1

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

Myofunctional Research Co

Unit 1 / 44 Siganto Drive

HELENSVALE, QLD, 4212

Australia

Products

1. Orthodontic appliance, retainer

Product Type

Single Device Product

Effective date

28/08/2019

GMDN

35310 Orthodontic appliance, retainer

Intended purpose

Used to assist in the correction of poor oral habits.

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 05:51:24 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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