ClearanceBrief
510(k) K971594 ยท EBF Material, Tooth Shade, Resin

FLOW-RITE

ApplicantPulpdent Corp., Watertown MA, US
DecisionSubstantially Equivalent, Sep 12, 1997
ReceivedMay 1, 1997
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K971594

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.