Jaw physiology evaluation system

Australia - English - Department of Health (Therapeutic Goods Administration)

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Available from:
Dentsply Sirona Pty Ltd
Class:
Class Im
Authorization status:
Included
Authorization number:
290955

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Public Summary

Summary for ARTG Entry:

290955

Dentsply Sirona Pty Ltd - Jaw physiology evaluation system

ARTG entry for

Medical Device Included Class Im

Sponsor

Dentsply Sirona Pty Ltd

Postal Address

19 / 39 Herbert Street,St Leonards, NSW, 2065

Australia

ARTG Start Date

4/07/2017

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

SICAT GmbH & Co KG

Brunnenallee 6

, Bonn, 53177

Germany

Products

1. Jaw physiology evaluation system

Product Type

Medical device system

Effective date

4/07/2017

GMDN

47556 Jaw physiology evaluation system

Intended purpose

An assembly of devices and software designed to record parameters for mandibular and muscles of

mastication function, primarily to aid in the diagnosis and treatment of temperomandibular joint (TMJ) and

myofascial pain dysfunction (MPD) disorders, and for orthodontic, denture, and reconstruction patient

evaluation. It typically uses surface electromyography to evaluate muscle groups at rest or in function;

sonography to detect sounds/vibrations from the TMJ joint and/or other computer-based system to

non-invasively track the mandible in function or identify its position in space relative to the skull.

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 03.11.2017 at 02:17:59 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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