ClearanceBrief
510(k) K260783 ยท EBF Material, Tooth Shade, Resin

Venus Diamond; Venus Diamond Flow; Venus Pearl; Venus Bulk Flow One

ApplicantKulzer, LLC, South Bend IN, US
DecisionSubstantially Equivalent, Mar 11, 2026
ReceivedMar 10, 2026
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K260783

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.