Bur, dental, diamond

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

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Available from:
Numedical Pty Ltd
Class:
Class 1
Authorization status:
Included
Authorization number:
291932

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Public Summary

Summary for ARTG Entry:

291932

Numedical Pty Ltd - Bur, dental, diamond

ARTG entry for

Medical Device Included Class 1

Sponsor

Numedical Pty Ltd

Postal Address

9-13 Hender Avenue,Magil, SA, 5072

Australia

ARTG Start Date

24/07/2017

Product category

Medical Device Class 1

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

Guangzhou Hicare Medical Equipment and

Materials Co Ltd

RM 413 Building 1 Guangdong Pharmaceutical

University

Guangzhou HEMC Xiaoguwei St

Panyu, Guangzhou,

China

Products

1. Bur, dental, diamond

Product Type

Single Device Product

Effective date

24/07/2017

GMDN

16670 Bur, dental, diamond

Intended purpose

Diamond dental bur,reusable;A rotary cutting device made of high-grade steel with the working end coated

with particles of diamond, and which is designed to fit into a dental handpiece that provides the rotation

allowing the user to cut hard structures in the mouth, such as teeth or bone. It can also be used to cut hard

metals, plastics, porcelains and similar materials intended for use in the fabrication of dental devices. This

is a reusable device.

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 10:55:21 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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