Clearance Summary
K5 Cart, K5 Mount, K5 Swing received FDA 510(k) clearance under submission number K251491, sponsored by Osstem Implant Company., Ltd. Chair Business. The device was reviewed via the Special premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2025-07-17.
- Submission: K251491
- Applicant / Sponsor: Osstem Implant Company., Ltd. Chair Business
- Clearance pathway: Special
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.6640
- Decision date: 2025-07-17
Classification & Regulation
This clearance is catalogued under FDA product code EIA and 21 CFR 872.6640, within the Dental review panel as a Class I device.