Device recall
Z-0917-2010: Sealapex Express (Part Number: 33639), root canal filling material. Manufactured…
FDA device recall · Class II · Sybron Dental Specialties
Key facts
| Recall number (Z-number) | Z-0917-2010 |
|---|---|
| Recall event | 53480 |
| Product | Sealapex Express (Part Number: 33639), root canal filling material. Manufactured by SybronEndo, Glendora, CA. Intended as a root canal filling material that is used in conjunction with gutta percha or silver endodontic points. |
| Product code | KIF |
| Recalling firm | Sybron Dental Specialties |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Mar 21, 2012 |
| 510(k) numbers | K040940 |
| FEI number | 2024312 |
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