510(k) K261134 ยท LRK Device, Anti-Snoring
Dormiva Anti-Snoring Mouth Guard
| Applicant | Koncept Innovators, Inc., Myrtle Beach SC, US |
| Decision | Substantially Equivalent, May 14, 2026 |
| Received | Apr 7, 2026 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K261134
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.