K253954
- 510(k) number
- K253954
- Device name
- X-Guide Surgical Navigation System
- Applicant
- X-Nav Technologies, LLC PA · US
- Product code
- QRY — Dental Navigation System
- Decision date
- 2026-08-28
- Date received
- 2025-12-10
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Dental
PDFDownload 510(k) SummaryArchived here · 1.0 MB · U.S. public domain
Also available from FDA: K253954.pdf
Official FDA record: K253954
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.