K251109
- 510(k) number
- K251109
- Device name
- SMARTDent
- Applicant
- Ray Co., Ltd. KR
- Product code
- LLZ — System, Image Processing, Radiological
- Decision date
- 2025-05-21
- Date received
- 2025-04-11
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Flag
- Third-party review
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 2.7 MB · U.S. public domain
Also available from FDA: K251109.pdf
Official FDA record: K251109
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.