Clearance Summary
els extra low shrinkage® composite & els extra low shrinkage® flow received FDA 510(k) clearance under submission number K240823, sponsored by Saremco Dental AG. The device was reviewed via the Abbreviated premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2024-06-27.
- Submission: K240823
- Applicant / Sponsor: Saremco Dental AG
- Clearance pathway: Abbreviated
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.3690
- Decision date: 2024-06-27
Classification & Regulation
This clearance is catalogued under FDA product code EBF and 21 CFR 872.3690, within the Dental review panel as a Class II device.