K251188
- 510(k) number
- K251188
- Device name
- UNIQA® Dental Implants System
- Applicant
- Uniqa Dental, Ltd. IL
- Product code
- DZE — Implant, Endosseous, Root-Form
- Decision date
- 2026-06-25
- Date received
- 2025-04-17
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Dental
PDFDownload 510(k) SummaryArchived here · 4.3 MB · U.S. public domain
Also available from FDA: K251188.pdf
Official FDA record: K251188
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.