ClearanceBrief
510(k) K243654 ยท MLY Vapocoolant Device

DentalJect

ApplicantVapocoolshot, Inc., Boca Raton FL, US
DecisionSubstantially Equivalent, May 30, 2025
ReceivedNov 26, 2024
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K243654

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.