K251129
- 510(k) number
- K251129
- Device name
- S.I.N. Tapered Pro Conical Zygoma Implant System
- Applicant
- S.I.N. Implant System Ltda BR
- Product code
- DZE — Implant, Endosseous, Root-Form
- Decision date
- 2025-11-07
- Date received
- 2025-04-11
- 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: K251129.pdf
Official FDA record: K251129
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.