K250872
- 510(k) number
- K250872
- Device name
- Bioline Dental Implant System
- Applicant
- Bioline Dental Implant Systems, Ltd. IL
- Product code
- DZE — Implant, Endosseous, Root-Form
- Decision date
- 2025-06-18
- Date received
- 2025-03-24
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Dental
PDFDownload 510(k) SummaryArchived here · 0.4 MB · U.S. public domain
Also available from FDA: K250872.pdf
Official FDA record: K250872
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.