Known Identifiers & Locations
FEI Numbers
1038806
Owner Operator Numbers
N/A
Locations Covered
N/A
Registered Establishments (0)
No device registration and listing records found for this entity.
510(k) Premarket Notifications (0)
No 510(k) notifications found for this entity.
FDA Recall History (1)
| Recall # |
Product Description |
Initiation Date |
Status |
Action |
| Z-0029-05 |
EP Healing Abutment- An abutment device is a premanufactured prosthetic component directly connected to the endosseous dental implant.
Reason: The nylon bag holding the product was not completely sealed before sterilization. Patients could be infected if the abutment is implanted.
|
2004-10-04 |
Terminated
|
View Details
|
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