Clearance Summary
Endo Motor (E-LITE MAX, E-LITE PRO, E-LITE INO) received FDA 510(k) clearance under submission number K242514, sponsored by Shenzhen Rogin Medical Co., Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2025-04-24.
- Submission: K242514
- Applicant / Sponsor: Shenzhen Rogin Medical Co., Ltd.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.4200
- Decision date: 2025-04-24
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.