K253883
- 510(k) number
- K253883
- Device name
- Bonalive Maxillofacial
- Applicant
- Bonalive , Ltd. FI
- Product code
- LYC — Bone Grafting Material, Synthetic
- Decision date
- 2026-05-14
- Date received
- 2025-12-04
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Dental
PDFDownload 510(k) SummaryArchived here · 0.7 MB · U.S. public domain
Also available from FDA: K253883.pdf
Official FDA record: K253883
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.