510(k) K214102 ยท MQC Mouthguard, Prescription
Glidewell Appliance Resin, Hard/Soft
| Applicant | Prismatik Dentalcraft, Inc., Irvine CA, US |
| Decision | Substantially Equivalent, Feb 23, 2022 |
| Received | Dec 29, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K214102
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.