ClearanceBrief
510(k) K161213 ยท EBW Controller, Foot, Handpiece And Cord

XSmart iQ

ApplicantDentsply Sirona, York PA, US
DecisionSubstantially Equivalent, Feb 10, 2017
ReceivedApr 29, 2016
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K161213

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.