Clearance Summary
REGEN Bioactive Cement received FDA 510(k) clearance under submission number K253337, 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 2026-04-15.
- Submission: K253337
- Applicant / Sponsor: Inter-Med, Inc.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.3275
- Decision date: 2026-04-15
Classification & Regulation
This clearance is catalogued under FDA product code EMA and 21 CFR 872.3275, within the Dental review panel as a Class II device.