Device Dossier

R.T.R.+ 40/60 - Bone matrix implant, synthetic

Device Dossier for R.T.R.+ 40/60 - Bone matrix implant, synthetic (Bone matrix implant, synthetic, Class III, sponsor Specialites Septodont). ARTG…

Intended purpose

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.

Functional description

This product is a microporous & microporous biphasic calcium phosphate ceramic consisting of 60% Hydroxyapatite (HA) & 40% beta-Tricalcium Phosphate (ß-TCP). Presented in a porous form required for the biological exchanges particularly for bone ingrowth. May be used with physiological saline, patient’s own serum, whole blood, or bone marrow aspirate (BMA). The Synthetic Bone Substitute is progressively replaced by new bone according to the remodelling process.

TGA Public Summary