Clearance Summary
e-SDF received FDA 510(k) clearance under submission number K240619, sponsored by Kids-E-Dental Llp. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2024-03-06.
- Submission: K240619
- Applicant / Sponsor: Kids-E-Dental Llp
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.3260
- Decision date: 2024-03-06
Classification & Regulation
This clearance is catalogued under FDA product code PHR and 21 CFR 872.3260, within the Dental review panel as a Class II device.