Device recall
Z-0750-2025: BYTE Aligner System REF PRS-0063 BYTE All-Day Aligner System BYTE AT-Night…
FDA device recall · Class II · Straight Smile, LLC
Key facts
| Recall number (Z-number) | Z-0750-2025 |
|---|---|
| Recall event | 95745 |
| Product | BYTE Aligner System REF PRS-0063 BYTE All-Day Aligner System BYTE AT-Night Aligner System A custom-made orthodontic appliance, typically supplied in series intended to be worn in succession and self-changed every few weeks, designed to influence the shape and/or function of the stomatognathic system… |
| Product code | NXC |
| Recalling firm | Straight Smile, LLC |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K230199 |
| FEI number | 3031789024 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 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