ClearanceBrief
510(k) K231775 ยท MQC Mouthguard, Prescription

GR Resin System MSI

ApplicantPro3Dure Medical, Iserlohn, DE
DecisionSubstantially Equivalent, Aug 8, 2024
ReceivedJun 16, 2023
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K231775

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.