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:
  • 216741
  • Last update:
  • 09-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

216741

Ormco Pty Ltd - CAD/CAM unit, dental, chairside

ARTG entry for

Medical Device Included Class 1

Sponsor

Ormco Pty Ltd

Postal Address

Unit 10 112-118 Talavera Road,NORTH RYDE, NSW, 2113

Australia

ARTG Start Date

31/10/2013

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

Ormco Corporation

1332 South Lone Hill Avenue

Glendora, CA, 91740

United States Of America

Products

1. CAD/CAM unit, dental, chairside

Product Type

Medical device system

Effective date

31/10/2013

GMDN

38597 CAD/CAM unit, dental, chairside

Intended purpose

The Lythos Digital Impression System for Orthodontic Use is an optical impression system intended for

use by dental professionals to record the topographical characteristics of teeth, gingiva, and/or palate. The

Lythos Digital Impression System is intended for use in conjunction with the production of orthodontic

appliances.

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 04:25:39 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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