Summary for ARTG Entry:
Dentrac Pty Ltd - Orthodontic bracket, metal
ARTG entry for
Medical Device Included Class IIa
Dentrac Pty Ltd
46 High Street,CARLTON, NSW, 2218
ARTG Start Date
Medical Device Class IIa
- 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.
Zhejiang Protect Medical Equipment Co Ltd
Science & Technology Zone Xiaofeng Town
Anji City, Zhejiang,
1. Orthodontic bracket, metal
Single Device Product
46581 Orthodontic bracket, metal
A metallic device that is bonded to an orthodontic band, or directly to a tooth, to hold an orthodontic wire
and/or other appliance (e.g., rubber bands) used to apply pressure to the tooth in order to alter the position
of the tooth.
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.
Page 1 of
Produced at 10.11.2017 at 03:24:34 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