510(k) K212448 ยท MQC Mouthguard, Prescription
NightGuard Flex
| Applicant | Sprintray, Inc., Los Angeles CA, US |
| Decision | Substantially Equivalent, Nov 12, 2021 |
| Received | Aug 5, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K212448
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.