510(k) K211415 ยท MQC Mouthguard, Prescription
GR Splint Resin System
| Applicant | Pro3Dure Medical GmbH, Iserlohn, DE |
| Decision | Substantially Equivalent, Oct 21, 2021 |
| Received | May 6, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K211415
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.