ClearanceBrief
510(k) K254112 ยท ELW Material, Impression

Dia-X Sil Bite

ApplicantDiaDent Group International, Cheongju-Si, KR
DecisionSubstantially Equivalent, Mar 19, 2026
ReceivedDec 19, 2025
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K254112

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.