ClearanceBrief
510(k) K250710 ยท KIF Resin, Root Canal Filling

Injectable Root Canal Bioceramic Sealer (nRoot SP)

ApplicantEnpuno Co., Ltd., Changsha, CN
DecisionSubstantially Equivalent, Jun 11, 2025
ReceivedMar 10, 2025
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K250710

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.