K251407
- 510(k) number
- K251407
- Device name
- Motor Handpiece and Control Unit (SDI10)
- Applicant
- Saeshin Precision Co., Ltd. KR
- Product code
- EBW — Controller, Foot, Handpiece And Cord
- Decision date
- 2026-01-30
- Date received
- 2025-05-06
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Dental
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K251407.pdf
Official FDA record: K251407
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.