510(k) K972424 ยท LRK Device, Anti-Snoring
SILENTNITE
| Applicant | Glidewell Laboratories, Newport Beach CA, US |
| Decision | Substantially Equivalent, Sep 18, 1997 |
| Received | Jun 27, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K972424
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 21, 2026 | Prismatik Dentalcraft, Inc. Brand Name: Silent Nite
Product Name: Silent Nite Sleep Appliance
Model/Catalog Number: SILNT
Product Description: Silent Nite Sleep Appliance is a mandibular advancement device (MAD) intended to t Open, Classified |
LRK | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.