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.. Device class: 1.
Summary
This clearance covers three portable dental units (PC 2630, OMC 2375CV, and MC 3600CV). Product code SJH covers portable dental operative units: base stations that deliver compressed air, water, suction, and power to handheld dental instruments, for use by dental professionals in non-permanent settings.
Class I, 21 CFR 872.6640. 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
- Product code SJH
- Device class
- Class 1
- Regulation
- 21 CFR 872.6640
- Advisory panel
- Dental
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Dongguan, CN
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