Summary for ARTG Entry:
Biomet 3i Australia Pty Ltd - Surgical procedure kit, dental, implant/prosthesis
ARTG entry for
Medical Device Included Class IIa
Biomet 3i Australia Pty Ltd
PO Box 1414,Macquarie Shopping Centre,NORTH RYDE, NSW, 2113
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.
Biomet 3i LLC T/a Implant Innovations
4555 Riverside Drive
Palm Beach Gardens, Florida, 33410
United States Of America
1. Surgical procedure kit, dental, implant/prosthesis
Medical device system
44883 Surgical procedure kit, dental, implant/prosthesis
A collection of various dental and prosthetic instruments necessary to perform a dental implant and
prosthetic surgical procedure. This device is reusable.
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 09.11.2017 at 10:30:05 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