ClearanceBrief
510(k) K191201 ยท DZE Implant, Endosseous, Root-Form

EM SA Implant System

ApplicantHiossen, Inc., Fariless Hills PA, US
DecisionSubstantially Equivalent, Nov 15, 2019
ReceivedMay 6, 2019
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K191201

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.