510(k) clearance
Portable Dental Unit (PC 2630, OMC 2375CV, MC 3600CV)
- 510(k) number
- K254009
- Applicant
- Lakong Medical Devices Co., Ltd.
- Decision date
- Sep 10, 2026
- Date received
- Dec 15, 2025
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Product code
- SJH
- Device type
- Portable Dental Operative Unit
- Device class
- Class I
- Regulation
- 21 CFR 872.6640
- Advisory committee
- Dental
- Statement or summary
- Statement
- Third party
- N
- Location
- Dongguan, CN