Australia - English - Department of Health (Therapeutic Goods Administration)
Summary for ARTG Entry:
Omni Melbourne - Custom-made orthopaedic surgical guide, non-sterile
ARTG entry for
Medical Device Included Class 1
40-42 Isabella Street,Moorabbin, VIC, 3189
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.
40-42 Isabella Street
Moorabbin, VIC, 3189
1. Custom-made orthopaedic surgical guide, non-sterile
Single Device Product
60826 Custom-made orthopaedic surgical guide, non-sterile
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.
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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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