K243078
- 510(k) number
- K243078
- Device name
- HexaPLUS S OneDrill Implant System
- Applicant
- Osseofuse International, Inc. NV · US
- Product code
- DZE — Implant, Endosseous, Root-Form
- Decision date
- 2025-10-10
- Date received
- 2024-09-30
- 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: K243078.pdf
Official FDA record: K243078
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.