Custom-made orthopaedic surgical guide, non-sterile

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Available from:

Omni Melbourne

Class:

Class I

Manufactured by:

Omni Melbourne 40-42 Isabella Street, Moorabbin, VIC, 3189 Australia

Therapeutic area:

60826 - Custom-made orthopaedic surgical guide, non-sterile

Therapeutic indications:

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.

Authorization status:

A

Authorization date:

2019-09-13