Clearance Summary
ReminGel received FDA 510(k) clearance under submission number K241489, sponsored by Inter-Med, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2025-01-08.
- Submission: K241489
- Applicant / Sponsor: Inter-Med, Inc.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.3260
- Decision date: 2025-01-08
Classification & Regulation
This clearance is catalogued under FDA product code LBH and 21 CFR 872.3260, within the Dental review panel as a Class II device.