Device Name: IngeniOS ß-TCP Bioactiv Synthetic Bone ParticlesIndications for Use:Oral and maxillofacial surgery and dentistry• Augmentation or reconstructive treatment of the alveolar ridge• Filling of infrabony periodontal defects• Filling of defects after root resection, apicoectomy, and cystectomy• Filing of extraction sockets to enhance preservation of the alveolar ridge• Elevation of the maxillary sinus floor
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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