Device recall
Z-1208-2023: SciCan STATIS SL S10001 Dental Handpieces-Intended for the removal of carious…
FDA device recall · Class II · Coltene Whaledent Inc
Key facts
| Recall number (Z-number) | Z-1208-2023 |
|---|---|
| Recall event | 91601 |
| Product | SciCan STATIS SL S10001 Dental Handpieces-Intended for the removal of carious material, reducing hard tooth structure, cavity preparation, finishing tooth preparations, restorations and for polishing teeth. Model Number: S10001 |
| Product code | EFB |
| Recalling firm | Coltene Whaledent Inc |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K071891 |
| FEI number | 2416455 |
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