K243692
- 510(k) number
- K243692
- Device name
- EnDrive (EnDriveUS)
- Applicant
- Advanced Technology Research (A.T.R.) S.R.L. IT
- Product code
- EKX — Handpiece, Direct Drive, Ac-Powered
- Decision date
- 2025-08-22
- Date received
- 2024-11-29
- 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: K243692.pdf
Official FDA record: K243692
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.