Clearance Summary
iCEM Universal Plus received FDA 510(k) clearance under submission number K254063, sponsored by Kulzer, LLC. The device was reviewed via the Abbreviated premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2025-12-19.
- Submission: K254063
- Applicant / Sponsor: Kulzer, LLC
- Clearance pathway: Abbreviated
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.3275
- Decision date: 2025-12-19
Classification & Regulation
This clearance is catalogued under FDA product code EMA and 21 CFR 872.3275, within the Dental review panel as a Class II device.