Awstralja - Ingliż - Department of Health (Therapeutic Goods Administration)
Summary for ARTG Entry:
Ultradent Australia Pty Ltd - Dental bonding agent, polymer based
ARTG entry for
Medical Device Included Class IIa
Ultradent Australia Pty Ltd
PO Box 111,Coogee, NSW, 2034
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.
Ultradent Products Inc
505 West Ultradent Drive 10200 South
South Jordan, Utah, 84095
United States Of America
1. Dental bonding agent, polymer based
Single Device Product
34782 Dental bonding agent, polymer based
Peak-ZM Zirconia/Metal Primer is intended for use as a surface treatment for restorations made of the
2. Alumina (Aluminum Oxide)
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Produced at 02.11.2019 at 06:00:21 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.
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