Device recall
Z-0811-2013: Ultradent Products, Chromaclone PVS, Regular Set heavy body, Bubble Gum Flavor…
FDA device recall · Class III · Ultradent Products, Inc.
Key facts
| Recall number (Z-number) | Z-0811-2013 |
|---|---|
| Recall event | 64272 |
| Product | Ultradent Products, Chromaclone PVS, Regular Set heavy body, Bubble Gum Flavor, 50 ml, Impression Material, Part No. 5012, Lot No. B7PPC. Used in prosthodontics. |
| Product code | ELW |
| Recalling firm | Ultradent Products, Inc. |
| Recall class | Class III |
| Status | Terminated |
| Termination date | May 30, 2013 |
| 510(k) numbers | K972027 |
| FEI number | 1718912 |
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