Diamond dental bur, single-use

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

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Available from:
Dentsply Sirona Pty Ltd
Class:
Class IIa
Authorization status:
Included
Authorization number:
323901

Public Summary

Summary for ARTG Entry:

323901

Dentsply Sirona Pty Ltd - Diamond dental bur, single-use

ARTG entry for

Medical Device Included Class IIa

Sponsor

Dentsply Sirona Pty Ltd

Postal Address

11-21 Gilby Road,Mt Waverley, VIC, 3149

Australia

ARTG Start Date

23/09/2019

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

Maillefer Instruments Holding Sarl

Chemin du Verger 3

Ballaigues, , CH-1338

Switzerland

Products

1. Diamond dental bur, single-use

Product Type

Single Device Product

Effective date

23/09/2019

GMDN

45525 Diamond dental bur, single-use

Intended purpose

This single use dental bur is to be used within a handpiece for the shaping and preparation of teeth

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 08.11.2019 at 10:04:07 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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