ClearanceBrief
510(k) K261888 ยท SHI Impression Material For Fabrication Of Patient-Matched Mouthguards, Over-The-Counter

ClearClub Impression Material

ApplicantClearClub, Inglewood CA, US
DecisionSubstantially Equivalent, Sep 16, 2026
ReceivedJun 5, 2026
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K261888

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.