510(k) K210694 ยท LRK Device, Anti-Snoring
Silent Nite Sleep Appliance with the Glidewell Hinge
| Applicant | Prismatik Dentalcraft, Inc., Irvine CA, US |
| Decision | Substantially Equivalent, Jun 16, 2021 |
| Received | Mar 8, 2021 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K210694
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.