ClearanceBrief
510(k) K163117 ยท NJM Bracket, Ceramic, Orthodontic

Alpha Pure

ApplicantKoroad America, Newport Beach CA, US
DecisionSubstantially Equivalent, May 9, 2017
ReceivedNov 7, 2016
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K163117

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.