ClearanceBrief
510(k) K122521 ยท EBC Sealant, Pit And Fissure, And Conditioner

PREVENT SEAL

ApplicantItena Clinical, Laval, CA
DecisionSubstantially Equivalent, Jun 11, 2013
ReceivedAug 20, 2012
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K122521

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.