Bur

Main information

  • Trade name:
  • Bur, dental, carbide
  • Class:
  • Class IIa
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Bur, dental, carbide
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 218524
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

218524

Ssoma Pty Ltd T/a CPC Creative Products - Bur, dental, carbide

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

13/12/2013

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

Intensiv SA

Via al Molino 107 6926- Montagnola

Switzerland

Products

1. Bur, dental, carbide

Product Type

Single Device Product

Effective date

13/12/2013

GMDN

16668 Bur, dental, carbide

Intended purpose

Carbide instruments for cutting and removal of crowns and bridges in metal and bonded metal/ceramic.

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 04:46:01 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

19-9-2018

Modification of the existing maximum residue levels for flonicamid in various root crops

Modification of the existing maximum residue levels for flonicamid in various root crops

Published on: Tue, 18 Sep 2018 00:00:00 +0200 In accordance with Article 6 of Regulation (EC) No 396/2005, the Agriculture and Horticulture Development Council submitted a request to the competent national authority in the United Kingdom to modify the existing maximum residue levels (MRL) for the active substance flonicamid in beetroots, carrots, celeriacs/turnip rooted celeries, horseradishes, Jerusalem artichokes, parsnips, parsley roots/Hamburg roots parsley, radishes, salsifies, swedes/rutabagas, tu...

Europe - EFSA - European Food Safety Authority Publications

3-7-2018

United States Bakery Issues Allergy Alert On Undeclared Milk In Naked Bread Hamburger Buns

United States Bakery Issues Allergy Alert On Undeclared Milk In Naked Bread Hamburger Buns

United States Bakery of Portland, Oregon is recalling Naked Bread Hamburger Buns #NothingToHide, 8 pack, affected lot codes F6 Best By June 16th, 2018 through July 16th 2018, because it may contain undeclared milk. People who have an allergy or severe sensitivity to milk run the risk of serious or life-threatening allergic reaction if they consume this product.

FDA - U.S. Food and Drug Administration

22-6-2018

June 20, 2018: Fitchburg Woman and Saugus Man Sentenced for Roles in Counterfeit Steroid Conspiracy

June 20, 2018: Fitchburg Woman and Saugus Man Sentenced for Roles in Counterfeit Steroid Conspiracy

June 20, 2018: Fitchburg Woman and Saugus Man Sentenced for Roles in Counterfeit Steroid Conspiracy

FDA - U.S. Food and Drug Administration

22-6-2018

Ierland sluit zich aan bij Beneluxa

Ierland sluit zich aan bij Beneluxa

Ierland heeft zich als vijfde land aangesloten bij het Beneluxa initiatief voor samenwerking op geneesmiddelenbeleid. Minister Bruno Bruins (Medische Zorg) en de Ierse minister van Volksgezondheid, Simon Harris, hebben hierover vandaag een overeenkomst getekend met hun Belgische, Luxemburgse en Oostenrijkse collega’s. De ondertekening vond plaats tijdens de Europese Raad van Ministers van Volksgezondheid (EPSCO) in Luxemburg. 

Netherlands - Ministerie van Volksgezondheid, Welzijn en Sport

14-6-2010

Changes in reimbursements for anti-ulcer medicines

Changes in reimbursements for anti-ulcer medicines

The Reimbursement Committee and the Danish Medicines Agency have reviewed medicinal products for the treatment of heartburns, sour eructations and ulcers ('acid-related disorders') in order to assess whether they meet the criteria for public reimbursement.

Danish Medicines Agency

21-9-2018

#FDA announces the 2nd Patient Engagement Advisory Committee meeting on November 15th at the Hilton Hotel in Gaithersburg, MD.

#FDA announces the 2nd Patient Engagement Advisory Committee meeting on November 15th at the Hilton Hotel in Gaithersburg, MD.

#FDA announces the 2nd Patient Engagement Advisory Committee meeting on November 15th at the Hilton Hotel in Gaithersburg, MD.

FDA - U.S. Food and Drug Administration