Drill

Main information

  • Trade name:
  • Drill, dental, remotely driven handpiece
  • Class:
  • Class IIa
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Drill, dental, remotely driven handpiece
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 220180
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

220180

Ssoma Pty Ltd T/a CPC Creative Products - Drill, dental, remotely driven handpiece

ARTG entry for

Medical Device Included Class IIa

Sponsor

Ssoma Pty Ltd T/a CPC Creative Products

Postal Address

PO Box 596,MARLESTON DC, SA, 5033

Australia

ARTG Start Date

15/02/2014

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

Intensiv SA

Via al Molino 107 6926- Montagnola

Switzerland

Products

1. Drill, dental, remotely driven handpiece

Product Type

Single Device Product

Effective date

15/02/2014

GMDN

38611 Drill, dental, remotely driven handpiece

Intended purpose

Powered handpiece including a chuck for attaching tools for use in dentistry including dental burs,

reamers, files, strips, contra angle handpieces and similar devices used in dentistry. Can be used for

rotating or oscillating devices.

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 02.12.2017 at 04:30:09 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

1-11-2018

Stanley Black & Decker Canada Corp. recalls certain Porter-Cable and Black & Decker hammer drills

Stanley Black & Decker Canada Corp. recalls certain Porter-Cable and Black & Decker hammer drills

The side handle supplied with the drill may slip when the drill is in use and lead to loss of control, posing a risk of injury.

Health Canada

There are no news related to this product.