ClearanceBrief
510(k) K251724 ยท SHI Impression Material For Fabrication Of Patient-Matched Mouthguards, Over-The-Counter

Remi Impression Material

ApplicantGrindguard, Inc., San Francisco CA, US
DecisionSubstantially Equivalent, Feb 25, 2026
ReceivedJun 4, 2025
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K251724

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.