Device Dossier

RESORBA Synthetic Bone Injectable - Bone matrix implant, synthetic

Device Dossier for RESORBA Synthetic Bone Injectable - Bone matrix implant, synthetic (Bone matrix implant, synthetic, Class III, sponsor Ozdent). ARTG…

Intended purpose

The Injectable Bone Substitute is intended to reconstruct contained bony voids or gaps in oral and maxillofacial applications. The Injectable Bone Substitute can be used with autograft as a bone graft extender. The Injectable Bone Substitute is indicated for filling/reconstruction surgically of 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 (B-TCP) granules associated with hydroxypropylmethylcellulose in an aqueous solution in a sterile syringe. Progressively replaced by new bone. Total resorption of the product depends on factors such as size and volume, location of the defect, surgical technique, health status of the patient. Bone reconstruction time is always inferior to the total resorption time.

TGA Public Summary