K252223
- 510(k) number
- K252223
- Device name
- Alpha Endo Handpiece (Alpha Endo)
- Applicant
- SHENZHEN SUPERLINE TECHNOLOGY CO., LTD. CN
- Product code
- EKX — Handpiece, Direct Drive, Ac-Powered
- Decision date
- 2025-10-16
- Date received
- 2025-07-16
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Dental
PDFDownload 510(k) SummaryArchived here · 0.4 MB · U.S. public domain
Also available from FDA: K252223.pdf
Official FDA record: K252223
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.