K253341
- 510(k) number
- K253341
- Device name
- Custom Abutments AS
- Applicant
- Medentika GmbH DE
- Product code
- NHA — Abutment, Implant, Dental, Endosseous
- Decision date
- 2025-12-23
- Date received
- 2025-09-30
- 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: K253341.pdf
Official FDA record: K253341
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.