Dental bonding agent, polymer based

Australien - engelska - Department of Health (Therapeutic Goods Administration)

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Tillgänglig från:
Ultradent Australia Pty Ltd
Klass:
Class IIa
Bemyndigande status:
Included
Godkännandenummer:
322280

Public Summary

Summary for ARTG Entry:

322280

Ultradent Australia Pty Ltd - Dental bonding agent, polymer based

ARTG entry for

Medical Device Included Class IIa

Sponsor

Ultradent Australia Pty Ltd

Postal Address

PO Box 111,Coogee, NSW, 2034

Australia

ARTG Start Date

27/08/2019

Product category

Medical Device Class IIa

Status

Active

Approval area

Medical Devices

Conditions

- 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.

Manufacturers

Name

Address

Ultradent Products Inc

505 West Ultradent Drive 10200 South

South Jordan, Utah, 84095

United States Of America

Products

1. Dental bonding agent, polymer based

Product Type

Single Device Product

Effective date

27/08/2019

GMDN

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 http://www.tga.gov.au/about/website-copyright.htm.

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.

Visit www.tga.gov.au for contact information

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