Clearance Summary
EnDrive (EnDriveUS) received FDA 510(k) clearance under submission number K243692, sponsored by Advanced Technology Research (A.T.R.) S.R.L.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2025-08-22.
- Submission: K243692
- Applicant / Sponsor: Advanced Technology Research (A.T.R.) S.R.L.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.4200
- Decision date: 2025-08-22
Classification & Regulation
This clearance is catalogued under FDA product code EKX and 21 CFR 872.4200, within the Dental review panel as a Class I device.