Device recall
Z-1100-2022: Affinity Hydroactive Impression Material Heavy Body Regular Set 12PK- A vinyl…
FDA device recall · Class II · Clinician's Choice Dental Products Inc.
Key facts
| Recall number (Z-number) | Z-1100-2022 |
|---|---|
| Recall event | 90031 |
| Product | Affinity Hydroactive Impression Material Heavy Body Regular Set 12PK- A vinyl poly siloxane material used to create, via impression, a reproduction of tooth and gum structure. Product ID: 013912 |
| Product code | ELW |
| Recalling firm | Clinician's Choice Dental Products Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Mar 19, 2024 |
| 510(k) numbers | K053014 |
| FEI number | 2018957 |
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