Device recall
Z-2769-2026: Brand Name: Silent Nite Product Name: Silent Nite Sleep Appliance Model/Catalog…
FDA device recall · Class II · Prismatik Dentalcraft, Inc.
Key facts
| Recall number (Z-number) | Z-2769-2026 |
|---|---|
| Recall event | 98834 |
| Product | 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 treat snoring and mild to moderate obstructive sleep apnea (OSA). |
| Product code | LRK |
| Recalling firm | Prismatik Dentalcraft, Inc. |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K183270, K972424 |
| FEI number | 3011649314 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database