ClearanceBrief
510(k) K082434 ยท EBF Material, Tooth Shade, Resin

GDLS-200

ApplicantGC America, Inc., Alsip IL, US
DecisionSubstantially Equivalent, Nov 14, 2008
ReceivedAug 25, 2008
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K082434

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.