Summary for ARTG Entry:
Dental Imagination Pty Ltd - Occlusal splint, dental, <specify>
ARTG entry for
Medical Device Included Class 1
Dental Imagination Pty Ltd
GPO Box 3733,SYDNEY, NSW, 2001
ARTG Start Date
Medical Device Class 1
- 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.
Uttenreuth, , 91080
1. Occlusal splint, dental, <specify>
Single Device Product
44360 Occlusal splint, dental, <specify>
This is a flexible appliance that is intended to overlay the occlusal surfaces of the teeth. It is used to
maintain the position of displaced or movable teeth, to treat clenching and bruxism and their sequelae, and
to provide temporary relief from muscle or temporo-mandibular joint (TMJ) conditions.
No Specific Conditions included on Record
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Produced at 10.11.2017 at 10:44:14 AEDT
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