Dental

Main information

  • Trade name:
  • Dental digital imaging sensor, intraoral
  • Class:
  • Class IIa
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Dental digital imaging sensor, intraoral
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 219918
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

219918

Centaur Software - Dental digital imaging sensor, intraoral

ARTG entry for

Medical Device Included Class IIa

Sponsor

Centaur Software

Postal Address

PO Box 2313,STRAWBERRY HILLS, NSW, 2012

Australia

ARTG Start Date

6/02/2014

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

Rayence Co Ltd

1F/2F/3F #402 14 Samsung 1ro 1-gil

Hwaseong-si, Gyeonggi-do,

Korea - Republic of

Products

1. Dental digital imaging sensor, intraoral

Product Type

Single Device Product

Effective date

6/02/2014

GMDN

44905 Dental digital imaging sensor, intraoral

Intended purpose

This is a device that is temporarily placed in a patient's mouth to perform routine diagnostic dental imaging

procedures. It uses analogue-to-digital conversion techniques to record the absorption pattern of x-ray

beams used in the diagnosis and treatment of diseases of the jaw or oral cavity structures. The device is

used in combination with the x-ray source (x-ray tube) that is located outside the patient's mouth during the

imaging procedure; the resulting digital image is transmitted to a monitor or workstation.

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 06:03:33 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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