510(k) K260031 · MQC Mouthguard, Prescription
THERMEO® I MSI
| Applicant | Pro3Dure Medical GmbH, Iserlohn, DE |
| Decision | Substantially Equivalent, Sep 29, 2026 |
| Received | Jan 6, 2026 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K260031
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.