Australia - English - Department of Health (Therapeutic Goods Administration)
Summary for ARTG Entry:
Sleep Sound Pty Ltd - Mandible-repositioning antisnoring orthosis
ARTG entry for
Medical Device Included Class 1
Sleep Sound Pty Ltd
Suite 2 71 Kooyong Road,Caulfield North, VIC, 3161
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.
Sleep Sound Pty Ltd
Suite 2 71 Kooyong Road
Caulfield North, VIC, 3161
1. Mandible-repositioning antisnoring orthosis
Single Device Product
47526 Mandible-repositioning antisnoring orthosis
A removable intraoral device designed to prevent snoring and/or obstructive sleep apnoea by repositioning
the lower jaw (mandible), frequently in a downward and forward position. It works by locking the mandible
(e.g., holding the teeth) and preventing it from retruding, thus increasing the patency of the airway and
decreasing both air turbulence and airway obstruction. The device is typically made of soft and/or hard
materials (e.g., plastics and metals); it may or may not be available [non-prescription] over-the-counter
(OTC). A number of different fixed (non-adjustable) and adjustable types using several techniques are
available. This is a reusable device.
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