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IngeniOS ß-TCP Bioactiv Synthetic Bone Particles

curasan AG · Model 0.25-1mm · UDI-DI 04260476431029

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510(k) clearances

Adverse events

Recalls

Facilities

Description

Device Name: IngeniOS ß-TCP Bioactiv Synthetic Bone Particles Indications 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

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.