R.T.R.+ 80/20 - Bone matrix implant, synthetic
Access comprehensive regulatory information for R.T.R.+ 80/20 - Bone matrix implant, synthetic in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class III is sponsored by Specialites Septodont Pty Ltd, manufactured by Biomatlante SA ZA les Quatre Nations in France. The device registration started on August 26, 2021.
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.
The Synthetic Bone Substitute is intended for use to reconstruct bony voids or bone gaps in particular in maxillofacial applications: - Periodontal/Intrabony defects filling - Ridge augmentation - Implant preparation, placement in extraction sites - Sinus lifts - Cystic cavities filling The performances of the Synthetic Bone Substitute are the filling of bone defects and the bony ingrowth from local osseous tissue onto the surface of the product (osteoconduction process). The total resorption of the product depends on numerous factors such as its size and volume, the location of the defect, the surgical technique, the health status of the patient. The bone reconstruction time is always inferior to the total resorption time.