510(k) K254009
K254009 is an FDA 510(k) premarket notification submitted by Lakong Medical Devices Co., Ltd. for the device "Portable Dental Unit (PC 2630, OMC 2375CV, MC 3600CV)". The FDA issued a decision of Substantially Equivalent on Sep 10, 2026. The device falls under product code SJH (Portable Dental Operative Unit), a Class I device regulated under 21 CFR 872.6640. Lakong Medical Devices Co., Ltd. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Sep 10, 2026
- Date Received
- Dec 15, 2025
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Portable Dental Operative Unit
- Device Class
- Class I
- Regulation Number
- 872.6640
- Review Panel
- DE
- Submission Type
A portable dental operative unit is a device intended to serve as a base station for dental instruments and accessories, delivering utilities such as compressed air, water, suction, and power to handheld dental instruments. The device is designed for use in non-permanent healthcare environments, including dental clinics, hospitals, mobile clinics, long-term care facilities, patient residences, schools, correctional facilities, military or humanitarian field settings, and similar settings, by dental professionals.