ClearanceBrief
510(k) K254009 ยท SJH Portable Dental Operative Unit

Portable Dental Unit (PC 2630, OMC 2375CV, MC 3600CV)

ApplicantLakong Medical Devices Co., Ltd., Dongguan, CN
DecisionSubstantially Equivalent, Sep 10, 2026
ReceivedDec 15, 2025
TypeTraditional
FDA recordOpen 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.