Australia - English - Department of Health (Therapeutic Goods Administration)
Summary for ARTG Entry:
Dentsply Sirona Pty Ltd - Jaw physiology evaluation system
ARTG entry for
Medical Device Included Class Im
Dentsply Sirona Pty Ltd
19 / 39 Herbert Street,St Leonards, NSW, 2065
ARTG Start Date
Medical Device Class Im
- 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.
SICAT GmbH & Co KG
, Bonn, 53177
1. Jaw physiology evaluation system
Medical device system
47556 Jaw physiology evaluation system
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.
No Specific Conditions included on Record
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Produced at 03.11.2017 at 02:17:59 AEDT
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