ClearanceBrief
510(k) K210977 ยท EBF Material, Tooth Shade, Resin

E-Dent 1000

ApplicantEnvisiontec GmbH, Gladbeck, DE
DecisionSubstantially Equivalent, May 25, 2021
ReceivedApr 1, 2021
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K210977

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.