Device Name: OSBONE® DENTAL lndications for Use: OSBONE® DENTAL is intended for the filling and reconstruction of multi-walled bone defects, e.g.: - Defects after removal of bone cysts - Augmentation of the atrophied alveolar ridge - Sinus lift and 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 - Support function for a membrane in controlled tissue regeneration (CTR) - Defects after surgical removal of retained teeth or corrective osteotomies - Other multi-walled bone defects of the alveolar processes
A sterile bioabsorbable device made of synthetic material implanted into the body to provide osteoconductive bone-tissue scaffolds to replace maxillofacial and/or mandibular bone lost through trauma or dental surgery. It is typically made of ceramics (e.g., tricalcium phosphate or hydroxyapatite), sometimes bioactive glasses or bioabsorbable polymers, and used to fill bone cavities and defects to promote the ingrowth of endogenous bone for skeletal reconstruction and/or augmentation. It is typically provided as sterile cancellous blocks, chips, or granules of varying sizes, or mouldable materials.
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