ARTG 323177Custom-made orthopaedic surgical guide, non-sterile
ARTG ID: 323177 · Omni Melbourne · Omni Melbourne · Class I · Started September 13, 2019
Good Name: Omni Melbourne - Custom-made orthopaedic surgical guide, non-sterile
- Risk Class
- Class I
- Product Type
- Single Device Product
- ARTG Category
- General
- ARTG ID
- 323177
- Start Date
- September 13, 2019
- Effective Date
- September 13, 2019
- Name
- Omni Melbourne
- Name
- Omni Melbourne
- Country
- Australia
- Address
- 40-42 Isabella Street, Moorabbin, VIC, 3189
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.
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 registered under ARTG number 323177 and sponsored by Omni Melbourne, manufactured by Omni Melbourne in Australia. The device registration started on September 13, 2019.
This page provides complete registration details including sponsor information, manufacturer details, and regulatory compliance data from the official Australia TGA ARTG medical device database. Pure Global AI offers free access to Australia's complete medical device registry with 131,000+ devices, helping global MedTech companies navigate TGA regulations efficiently.