510(k) K220894 ยท MQC Mouthguard, Prescription
SmileGuard
| Applicant | Envisiontec GmbH, Gladbeck, DE |
| Decision | Substantially Equivalent, Jun 10, 2022 |
| Received | Mar 28, 2022 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K220894
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.