K251818
- 510(k) number
- K251818
- Device name
- BONTREE PLUS
- Applicant
- Hudens Bio Co., Ltd. KR
- Product code
- LYC — Bone Grafting Material, Synthetic
- Decision date
- 2026-03-06
- Date received
- 2025-06-13
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Dental
PDFDownload 510(k) SummaryArchived here · 0.7 MB · U.S. public domain
Also available from FDA: K251818.pdf
Official FDA record: K251818
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.