EnDrive (EnDriveUS)
FDA 510(k) K243692 · Advanced Technology Research (A.T.R.) S.R.L.
510(k) numberK243692
Submission
- Device name
- EnDrive (EnDriveUS)
- Applicant
- Advanced Technology Research (A.T.R.) S.R.L.
Pistoia, IT - Received
- November 29, 2024
- Decision date
- August 22, 2025
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was EnDrive (EnDriveUS) cleared by the FDA?
EnDrive (EnDriveUS) (K243692) received a 510(k) decision of Substantially Equivalent on August 22, 2025, 266 days after the submission was received.
What is the product code of K243692?
The FDA product code is EKX – Handpiece, Direct Drive, Ac-Powered, a Class I (low risk) device regulated under 21 CFR 872.4200.