K243278
- 510(k) number
- K243278
- Device name
- Custom Abutments
- Applicant
- Institut Straumann AG CH
- Product code
- NHA — Abutment, Implant, Dental, Endosseous
- Decision date
- 2025-02-21
- Date received
- 2024-10-16
- 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: K243278.pdf
Official FDA record: K243278
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.