Fixture/appliance dental drill, reusable

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

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Available from:
Wright Medical Australia Pty Ltd
Class:
Class IIa
Authorization status:
Included
Authorization number:
321964

Public Summary

Summary for ARTG Entry:

321964

Wright Medical Australia Pty Ltd - Fixture/appliance dental drill, reusable

ARTG entry for

Medical Device Included Class IIa

Sponsor

Wright Medical Australia Pty Ltd

Postal Address

PO Box 6043,Frenchs Forest DC, NSW, 2086

Australia

ARTG Start Date

19/08/2019

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

SARL CHOC

3 Rue Louis Lepine

Albasud, Montauban, 82000

France

Products

1. Fixture/appliance dental drill, reusable

Product Type

Single Device Product

Effective date

19/08/2019

GMDN

45714 Fixture/appliance dental drill, reusable

Intended purpose

An Orthopaedic drill bit used in surgical procedures to create a channel of appropriate depth and diameter

in bone (osteotomy) to facilitate the implantation of an implantable device. It is attached to a motorized

handpiece or other power source that provides rotation. This is a reusable device.

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 06:35:01 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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