K242514
- 510(k) number
- K242514
- Device name
- Endo Motor (E-LITE MAX, E-LITE PRO, E-LITE INO)
- Applicant
- Shenzhen Rogin Medical Co., Ltd. CN
- Product code
- EKX — Handpiece, Direct Drive, Ac-Powered
- Decision date
- 2025-04-24
- Date received
- 2024-08-23
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Dental
PDFDownload 510(k) SummaryArchived here · 1.0 MB · U.S. public domain
Also available from FDA: K242514.pdf
Official FDA record: K242514
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.