K253493
- 510(k) number
- K253493
- Device name
- Dentis SQ-SL AXEL Fixture
- Applicant
- Dentis Co., Ltd. KR
- Product code
- DZE — Implant, Endosseous, Root-Form
- Decision date
- 2026-03-04
- Date received
- 2025-10-27
- 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: K253493.pdf
Official FDA record: K253493
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.