ClearanceBrief
510(k) K170812 ยท ELW Material, Impression

HygePLUS Alginate Impression Material

ApplicantHygedent, Inc., Beijing, CN
DecisionSubstantially Equivalent, Jul 26, 2017
ReceivedMar 17, 2017
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K170812

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.