CAD CAM

Main information

  • Trade name:
  • CAD/CAM unit, dental, chairside
  • Class:
  • Class Im
  • 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:
  • 221378
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

221378

3M Australia Pty Ltd - CAD/CAM unit, dental, chairside

ARTG entry for

Medical Device Included Class Im

Sponsor

3M Australia Pty Ltd

Postal Address

Locked Bag 19,NORTH RYDE BC, NSW, 1670

Australia

ARTG Start Date

18/03/2014

Product category

Medical Device Class Im

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

3M Espe Dental Products

2510 Conway Avenue

St Paul, Minnesota, 55144-1000

United States Of America

Products

1. CAD/CAM unit, dental, chairside

Product Type

Medical device system

Effective date

18/03/2014

GMDN

38597 CAD/CAM unit, dental, chairside

Intended purpose

3M True Definition Scanner is an optical impression system used to record the topographical

characteristics of the dentition and preparation areas (including features such as implant scan locator

fixtures, braces, brackets, etc.). In addition it can record the

topographical characteristics of the oral anatomy (such as soft tissue, gingiva and palate). The three

dimensional (3D) model generated from the scan may be further used for the design and manufacturing of

dental restorations including implant supported prostheses, and partial frameworks, and can be used to

design and manufacture physical models of the teeth. It may also be used in conjunction with production of

orthodontic appliances, retainers and accessories.

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 01:17:17 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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