ClearanceBrief
510(k) K260790 ยท OBR Mouthguard, Over-The-Counter

G-Series Grind Guard

ApplicantASESSO HEALTH, Inc., Pleasanton CA, US
DecisionSubstantially Equivalent, Jun 25, 2026
ReceivedMar 11, 2026
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K260790

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.