K230108
- 510(k) number
- K230108
- Device name
- Straumann® BLC and TLC Implants
- Applicant
- Institut Straumann AG CH
- Product code
- DZE — Implant, Endosseous, Root-Form
- Decision date
- 2023-09-14
- Date received
- 2023-01-13
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Dental
PDFDownload 510(k) SummaryArchived here · 0.6 MB · U.S. public domain
Also available from FDA: K230108.pdf
Official FDA record: K230108
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.