Dental bonding agent, polymer based

Austrália - angličtina - Department of Health (Therapeutic Goods Administration)

Kúpte ho teraz

Dostupné z:
Ultradent Australia Pty Ltd
Class IIa
Stav Autorizácia:
Číslo povolenia:

Public Summary

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

Postal Address

PO Box 111,Coogee, NSW, 2034


ARTG Start Date


Product category

Medical Device Class IIa



Approval area

Medical Devices


- 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

Product Type

Single Device Product

Effective date



34782 Dental bonding agent, polymer based

Intended purpose

Peak-ZM Zirconia/Metal Primer is intended for use as a surface treatment for restorations made of the

following materials:

1. Zirconia

2. Alumina (Aluminum Oxide)

3. Metal/alloy

4. Titanium

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

Public Summary

Page 1 of

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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