K231127
- 510(k) number
- K231127
- Device name
- S.I.N. Dental Implant System
- Applicant
- S.I.N. - Sistema DE Implante Nacional S.A. BR
- Product code
- DZE — Implant, Endosseous, Root-Form
- Decision date
- 2023-12-07
- Date received
- 2023-04-20
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Dental
PDFDownload 510(k) SummaryArchived here · 1.2 MB · U.S. public domain
Also available from FDA: K231127.pdf
Official FDA record: K231127
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.