Dental digital imaging sensor, intraoral

Australia - English - Department of Health (Therapeutic Goods Administration)

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Available from:
Kerr Australia Pty Ltd
Class:
Class IIa
Authorization status:
Included
Authorization number:
290010

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Public Summary

Summary for ARTG Entry:

290010

Kerr Australia Pty Ltd - Dental digital imaging sensor, intraoral

ARTG entry for

Medical Device Included Class IIa

Sponsor

Kerr Australia Pty Ltd

Postal Address

Unit 10 112-118 Talavera Road,NORTH RYDE, NSW, 2113

Australia

ARTG Start Date

9/06/2017

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

Dental Imaging Technology Corporation

1910 North Penn Road

Hatfield, PA, 19440

United States Of America

Products

1. Dental digital imaging sensor, intraoral

Product Type

Single Device Product

Effective date

9/06/2017

GMDN

44905 Dental digital imaging sensor, intraoral

Intended purpose

this is an analogue device that is temporarily placed in a patient's mouth that is inteded to be used to

perform routine diagnostic dental imaging procedures.

Specific Conditions

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.

Public Summary

Page 1 of

Produced at 03.11.2017 at 05:17:53 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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