ClearanceBrief
510(k) K260569 ยท EBI Resin, Denture, Relining, Repairing, Rebasing

DB 4000 High Impact Denture Base

ApplicantCarbon, Inc., Sunnyvale CA, US
DecisionSubstantially Equivalent, Jun 2, 2026
ReceivedFeb 19, 2026
TypeAbbreviated
FDA recordOpen on fda.gov

Recalls that name K260569

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.