Portable Dental Unit (PC 2630, OMC 2375CV, MC 3600CV)— 510(k) K254009
Substantially EquivalentLakong Medical Devices Co., Ltd.
FDA 510(k) clearance K254009 for Portable Dental Unit (PC 2630, OMC 2375CV, MC 3600CV), Substantially Equivalent on 2026-09-10. Applicant: Lakong Medical Devices Co., Ltd..
Summary
This clearance covers three portable dental units (PC 2630, OMC 2375CV, and MC 3600CV). Portable units bundle handpiece drive, air, water, and suction into a mobile cart or case for treatment outside a fixed operatory.
The record lists product code SJH but no name, class, or regulation for it. That usually means the code is too new for openFDA's classification data to have caught up. The Dental panel reviewed it as a Traditional 510(k).
Lakong Medical Devices filed from Dongguan, China. Review took 269 days (December 15, 2025 to September 10, 2026).
Clearance details
- Applicant
- Lakong Medical Devices Co., Ltd.
- Product code
- Code SJH
- Advisory panel
- Dental
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Dongguan, CN
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