510(k) K262421 ยท SHI Impression Material For Fabrication Of Patient-Matched Mouthguards, Over-The-Counter
Daybreak Impression Material
| Applicant | Sleepcare, LLC, Los Angeles CA, US |
| Decision | Substantially Equivalent, Oct 20, 2026 |
| Received | Jul 16, 2026 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K262421
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.