Clearance Summary
SDF Pro received FDA 510(k) clearance under submission number K250222, sponsored by Belport Company, Inc., Gingi-Pak. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2025-05-07.
- Submission: K250222
- Applicant / Sponsor: Belport Company, Inc., Gingi-Pak
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.3260
- Decision date: 2025-05-07
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.