Device Dossier

Cerasorb M Granules - Graft, bone, synthetic

Device Dossier for Cerasorb M Granules - Graft, bone, synthetic (Graft, bone, synthetic, Class III, sponsor Dental Integrated Dynamics). ARTG record,…

Intended purpose

This is material is intended to be used for the filling, bridging and reconstruction of bone defects and for bone fusion. This synthetic bone grafting material supports the structure of the patients bone and is fully resorbed while new bone is formed. This material is an alternative to cancellous bone due to its chemical and biological properties which ensure physiological defect repair. General bone surgery • Filling, bridging and/or reconstruction of non?infected bone defects • Plastic reconstruction of damaged bone regions • Bone fusion, e.g. spinal fusion • Filling of intervertebral implants Oromaxillofacial surgery and dentistry Filling and reconstruction of single and multi?walled bone defects, e.g.: • Defects after removal of bone cysts • Augmentation of the atrophic alveolar ridge • Sinus floor elevation (subantral augmentation) • Filling of alveolar defects following tooth extraction for alveolar ridge preservation • Filling of extraction defects to create an implant bed • Filling of two? or multi?walled infrabony pockets, and bi? and trifurcation defects • Defects after surgical removal of retained teeth or corrective osteotomies • Other multi?walled bone defects of the alveolar ridge and facial skull The clinical data for use with PRP shows that the addition of PRP increases the bone regeneration rate somewhat, at the expense of possible immunologic reaction with formation of foreign-body giant cells.‘Cerasorb M morsels cannot assume any load-bearing function during the initial healing phase. Depending on the nature and site of the bone defect to be treated, additional osteosynthetic measures may be required.’

Functional description

Resorbable, pure-phase beta-tricalcium phosphate implant matrix,filling, bridging, reconstruction of bone defects and bone fusion. A synthetic, porous biocompatible ceramic material with a phase purity of ?99%.It's interconnecting, open-pore structure with micro, meso and macro pores. It is polygonal morsels. It is in contact with vital bone and resorbed by the body over a period of months and simultaneously replaced by local, endogenous bone.

TGA Public Summary