Australia - English - Department of Health (Therapeutic Goods Administration)
Summary for ARTG Entry:
Dentsply Sirona Pty Ltd - Resin-composite dental cement
ARTG entry for
Medical Device Included Class 1
Dentsply Sirona Pty Ltd
11-21 Gilby Road,Mt Waverley, VIC, 3149
ARTG Start Date
Medical Device Class 1
- 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.
Dentsply LLC also dba Dentsply Caulk
38 West Clarke Avenue
Milford, Delaware, 19963
United States Of America
1. Resin-composite dental cement
Single Device Product
35870 Resin-composite dental cement
Dental composite resin restorative material with flow characteristics for use in small cavities in anterior and
© 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 02.11.2019 at 03:07:25 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