K241391
- 510(k) number
- K241391
- Device name
- Straumann® PURE Ceramic Implants
- Applicant
- Institut Straumann AG CH
- Product code
- DZE — Implant, Endosseous, Root-Form
- Decision date
- 2024-12-10
- Date received
- 2024-05-15
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Dental
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K241391.pdf
Official FDA record: K241391
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.