K253009
- 510(k) number
- K253009
- Device name
- DS Core Detect
- Applicant
- Dentsply Sirona, Inc. PA · US
- Product code
- MYN — Analyzer, Medical Image
- Decision date
- 2026-01-07
- Date received
- 2025-09-19
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 1.5 MB · U.S. public domain
Also available from FDA: K253009.pdf
Official FDA record: K253009
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.