K231562
- 510(k) number
- K231562
- Device name
- ELEC ENGINE (Model: ISE-170L)
- Applicant
- Micro-Nx Co., Ltd. KR
- Product code
- EBW — Controller, Foot, Handpiece And Cord
- Decision date
- 2025-07-18
- Date received
- 2023-05-31
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Dental
PDFDownload 510(k) SummaryArchived here · 0.4 MB · U.S. public domain
Also available from FDA: K231562.pdf
Official FDA record: K231562
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.