K241003
- 510(k) number
- K241003
- Device name
- HIOSSEN Pre-milled Abutment (ET Pre-milled Abutment & EK Pre-milled Abutment)
- Applicant
- Hiossen, Inc. PA · US
- Product code
- NHA — Abutment, Implant, Dental, Endosseous
- Decision date
- 2025-01-08
- Date received
- 2024-04-12
- Decision
- Substantially Equivalent
- Clearance type
- Abbreviated
- Advisory committee
- Dental
PDFDownload 510(k) SummaryArchived here · 0.6 MB · U.S. public domain
Also available from FDA: K241003.pdf
Official FDA record: K241003
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.