Custom-made orthopaedic surgical guide, non-sterile

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

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Available from:
Omni Melbourne
Class 1
Authorization status:
Authorization number:

Public Summary

Summary for ARTG Entry:


Omni Melbourne - Custom-made orthopaedic surgical guide, non-sterile

ARTG entry for

Medical Device Included Class 1


Omni Melbourne

Postal Address

40-42 Isabella Street,Moorabbin, VIC, 3189


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.




Omni Melbourne

40-42 Isabella Street

Moorabbin, VIC, 3189



1. Custom-made orthopaedic surgical guide, non-sterile

Product Type

Single Device Product

Effective date



60826 Custom-made orthopaedic surgical guide, non-sterile

Intended purpose

This is a device that contains 3 surgical guides that have been custom made, patient specific and single

use as a result of being prepared via a 3-D printing technique using CAD/CAM technologies.

These surgical guides have been specifically designed as an integral single-use device that are intended

to be used for locating the anchor pins as part of customising the AuDentes prosthetic Bridge, guiding the

osteotomy of the maxilla and/or mandible as well as implanting the dental prosthetic devices which

permanently retain the bridge.

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

Page 1 of

Produced at 08.11.2019 at 10:43:48 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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