510(k) K223798 · MQC Mouthguard, Prescription
Glidewell TuffSplint Appliance Resin
| Applicant | Prismatik Dentalcraft, Inc., Irvine CA, US |
| Decision | Substantially Equivalent, Feb 17, 2023 |
| Received | Dec 19, 2022 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K223798
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.