Saw attachment

Main information

  • Trade name:
  • Saw attachment, dental
  • Class:
  • Class IIa
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Saw attachment, dental
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 217595
  • Last update:
  • 09-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

217595

Gunz Dental Pty Ltd - Saw attachment, dental

ARTG entry for

Medical Device Included Class IIa

Sponsor

Gunz Dental Pty Ltd

Postal Address

Locked Bag 5000,ALEXANDRIA, NSW, 2015

Australia

ARTG Start Date

21/11/2013

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

Bien Air Dental SA

Langgasse 60

Bienne, , CH-2504

Switzerland

Products

1. Saw attachment, dental

Product Type

Single Device Product

Effective date

21/11/2013

GMDN

45574 Saw attachment, dental

Intended purpose

This is a device,with a straight, contra-angle or right-angle attachment, that is connected to a dedicated

saw or drill/saw handpiece that is intended to be used to facilitate the sawing function used in

maxillofacial/dental surgery.

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 10.11.2017 at 01:44:41 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

5-11-2018

STIHL Limited recalls STIHL MSA 161 T Battery Operated Arborist Chain Saw

STIHL Limited recalls STIHL MSA 161 T Battery Operated Arborist Chain Saw

The side inter-lock button may stick when gripping the machine, which could cause the throttle trigger to remain depressed and the chain to continue to run even after releasing the throttle trigger. This can pose a risk of laceration to the user or bystander.

Health Canada

19-7-2018

Makita Canada Inc. recalls Makita and Dolmar Chainsaws

Makita Canada Inc. recalls Makita and Dolmar Chainsaws

The automatic chain brake does not easily engage when the saw kicks back, possibly exposing the user to contact with the chain while it is still moving, posing a laceration hazard.

Health Canada

13-11-2018

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FDA - U.S. Food and Drug Administration

6-11-2018

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FDA - U.S. Food and Drug Administration

11-10-2018

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FDA - U.S. Food and Drug Administration