Device Dossier
RESORBA Synthetic Bone - Bone matrix implant, synthetic
Device Dossier for RESORBA Synthetic Bone - Bone matrix implant, synthetic (Bone matrix implant, synthetic, Class III, sponsor Ozdent). ARTG record,…
- GMDN category: Bone matrix implant, synthetic
Intended purpose
The Synthetic Bone Substitute is intended for use to reconstruct bony voids or bone gaps in maxillofacial/oral applications. The Synthetic Bone Substitute can be used with autograft as a bone graft extender. The Synthetic Bone Substitute is indicated for filling/ reconstruction of surgically created bony voids, or bone gaps / osseous defects created from traumatic injury to the bone in maxillofacial/oral applications.
Functional description
Microporous & macroporous biphasic calcium phosphate ceramic consisting of 60% Hydroxyapatite (HA) & 40% beta-Tricalcium Phosphate (fs-TCP). May be used with physiological saline, patient's own serum, whole blood, or bone marrow aspirate. Progressively replaced by new bone. The total resorption of the product depends on factors such as size & volume, location of defect, surgical technique, health status of the patient. Bone reconstruction time is always inferior to the total resorption time.