Mandible-repositioning antisnoring orthosis

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

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Sleep Sound Pty Ltd
Class 1
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Authorization number:

Public Summary

Summary for ARTG Entry:


Sleep Sound Pty Ltd - Mandible-repositioning antisnoring orthosis

ARTG entry for

Medical Device Included Class 1


Sleep Sound Pty Ltd

Postal Address

Suite 2 71 Kooyong Road,Caulfield North, VIC, 3161


ARTG Start Date


Product category

Medical Device Class 1



Approval area

Medical Devices


- 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

Product Type

Single Device Product

Effective date



47526 Mandible-repositioning antisnoring orthosis

Intended purpose

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.

Specific Conditions

© 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

Public Summary

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Produced at 02.11.2019 at 04:36:50 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.

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