Custom-made orthopaedic surgical guide, non-sterile
Access comprehensive regulatory information for Custom-made orthopaedic surgical guide, non-sterile in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class I is sponsored by Omni Melbourne, manufactured by Omni Melbourne in Australia. The device registration started on September 13, 2019.
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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.