ClearanceBrief
510(k) K162598 ยท EBC Sealant, Pit And Fissure, And Conditioner

HAPI Seal

ApplicantBisco, Inc., Schaumburg IL, US
DecisionSubstantially Equivalent, May 23, 2017
ReceivedSep 19, 2016
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K162598

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.