CAD CAM

Main information

  • Trade name:
  • CAD/CAM unit, dental, chairside
  • Class:
  • Class 1
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • CAD/CAM unit, dental, chairside
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 220220
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

220220

Henry Schein Halas - CAD/CAM unit, dental, chairside

ARTG entry for

Medical Device Included Class 1

Sponsor

Henry Schein Halas

Postal Address

Locked Bag 5003,ALEXANDRIA, NSW, 2015

Australia

ARTG Start Date

17/02/2014

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

Planmeca Oy

Asentajankatu 6

Helsinki, , 00880

Finland

Products

1. CAD/CAM unit, dental, chairside

Product Type

Single Device Product

Effective date

17/02/2014

GMDN

38597 CAD/CAM unit, dental, chairside

Intended purpose

Acts as a scanner for digital 3D impressions, thus help produce continous 3D model of a single tooth, quad

or an arch, so can be used to design and mill inlays, onlays, veneers, crowns and bridges.

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 04:53:05 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

27-9-2018

Mauna Loa Macadamia Nut Corporation Voluntarily Recalls

Mauna Loa Macadamia Nut Corporation Voluntarily Recalls

Mauna Loa Macadamia Nut Corporation is voluntarily recalling all of its products produced at the Keaau facility between Sept. 6 - 21, 2018 due to a potential contamination of Escherichia coli (E. coli). The recall was initiated due to E. coli being detected in the well water and distribution system that supplies the firm's operations. No illnesses related to the water have been reported to the state.

FDA - U.S. Food and Drug Administration

14-9-2018

Pending EC decision:  Inflacam, meloxicam, Opinion date: 13-Sep-2018

Pending EC decision: Inflacam, meloxicam, Opinion date: 13-Sep-2018

Europe - EMA - European Medicines Agency

24-9-2018

Mektovi (Pierre Fabre MEdicament)

Mektovi (Pierre Fabre MEdicament)

Mektovi (Active substance: binimetinib) - Centralised - Authorisation - Commission Decision (2018)6217 of Mon, 24 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/004579/0000

Europe -DG Health and Food Safety

24-9-2018

Braftovi (Pierre Fabre MEdicament)

Braftovi (Pierre Fabre MEdicament)

Braftovi (Active substance: encorafenib) - Centralised - Authorisation - Commission Decision (2018)6216 of Mon, 24 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/004580/0000

Europe -DG Health and Food Safety