Clearance Summary
Portable Dental Unit (PC 2630, OMC 2375CV, MC 3600CV) received FDA 510(k) clearance under submission number K254009, sponsored by Lakong Medical Devices Co., Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2026-09-10.
- Submission: K254009
- Applicant / Sponsor: Lakong Medical Devices Co., Ltd.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.6640
- Decision date: 2026-09-10
Classification & Regulation
This clearance is catalogued under FDA product code SJH and 21 CFR 872.6640, within the Dental review panel as a Class I device.