Clearance Summary
els unibond received FDA 510(k) clearance under submission number K252151, sponsored by Saremco Dental AG. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2025-12-05.
- Submission: K252151
- Applicant / Sponsor: Saremco Dental AG
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.3200
- Decision date: 2025-12-05
Classification & Regulation
This clearance is catalogued under FDA product code KLE and 21 CFR 872.3200, within the Dental review panel as a Class II device.