510(k) K254009 ยท SJH Portable Dental Operative Unit
Portable Dental Unit (PC 2630, OMC 2375CV, MC 3600CV)
| Applicant | Lakong Medical Devices Co., Ltd., Dongguan, CN |
| Decision | Substantially Equivalent, Sep 10, 2026 |
| Received | Dec 15, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K254009
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.