Known Identifiers & Locations
FEI Numbers
1821514
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 (2)
| Recall # |
Product Description |
Initiation Date |
Status |
Action |
| Z-0035-2008 |
Heraeus Kulzer GLUMA Comfort Bond + Desensitizer light curing one component adhesive, contents: 4 ml, dental bonding agent. Distributed by Heraeus Kulzer, Inc., Armonk, NY; Reorder No. 66001710.
Reason: The material may solidify in the bottle, and thus be rendered unusable.
|
2007-07-09 |
Terminated
|
View Details
|
| Z-0036-2008 |
Heraeus Kulzer GLUMA Comfort Bond + Desensitizer light curing one component adhesive, Assortment Value Pack 3 x 4 ml, dental bonding agent. Distributed by Heraeus Kulzer, Inc., Armonk, NY; Reorder No. 66018222.
Reason: The material may solidify in the bottle, and thus be rendered unusable.
|
2007-07-09 |
Terminated
|
View Details
|
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