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:
  • 218268
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

218268

WT Australia Pty Ltd - CAD/CAM unit, dental, chairside

ARTG entry for

Medical Device Included Class 1

Sponsor

WT Australia Pty Ltd

Postal Address

12 Stott Place,BULL CREEK, WA, 6149

Australia

ARTG Start Date

7/12/2013

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

Sirona Dental Systems GmbH

Fabrik Strasse 31

Bensheim, , D 64625

Germany

Products

1. CAD/CAM unit, dental, chairside

Product Type

Medical device system

Effective date

7/12/2013

GMDN

38597 CAD/CAM unit, dental, chairside

Intended purpose

Optical impression system (CAD/CAM) used to record the topographical characteristics of teeth directly

from the patient's mouth for use with CAD/CAM dental restoration design and production of specific types

of indications: Single crowns, three-unit bridges, inlays, onlays, and veneers.

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 11:08:57 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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