Clearance Summary
ELEC ENGINE (Model: ISE-170L) received FDA 510(k) clearance under submission number K231562, sponsored by Micro-Nx Co., Ltd.. The device was reviewed via the Special premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2025-07-18.
- Submission: K231562
- Applicant / Sponsor: Micro-Nx Co., Ltd.
- Clearance pathway: Special
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.4200
- Decision date: 2025-07-18
Classification & Regulation
This clearance is catalogued under FDA product code EBW and 21 CFR 872.4200, within the Dental review panel as a Class I device.