K250317
- 510(k) number
- K250317
- Device name
- EsFlow PLUS
- Applicant
- Spident Co., Ltd. KR
- Product code
- EBF — Material, Tooth Shade, Resin
- Decision date
- 2025-05-30
- Date received
- 2025-02-04
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Dental
PDFDownload 510(k) SummaryArchived here · 0.7 MB · U.S. public domain
Also available from FDA: K250317.pdf
Official FDA record: K250317
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.