Device product
IPS e.max ZirCAD CER/in. Prime A3 C17/5 -A zirconium oxide block for the fabrication of fixed, full-contour restorations in anterior and posterior teeth Article Number: 758439
Z-1706-2024
Product summary
- Event
- Event 94401
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 12525 units
- Official record key
device-enforcement:Z-1706-2024
Official wording
Reason: Defective blocks may show cracks after sintering If cracks are unnoticed, restorations may fracture in the patient's mouth and require restoration
Code information: UDI-DI: (01)07615208438659 (11)231117 (10)Z063MT (241)758439; (01)07615208438659 (11)231214 (10)Z067JF (241)758439; (01)07615208438659 (11)231214 (10)Z067JC (241)758439; (01)07615208438659 (11)231214 (10)Z067JG (241)758439; (01)07615208438659 (11)231214 (10)Z067JB (241)758439; (01)07615208438659 (11)240105 (10)Z06B6Z (241)758439; (01)07615208438659 (11)240112 (10)Z06CBG (241)758439 Batch No. Z063MT, Z067JF, Z067JC, Z067JG, Z067JB, Z06B6Z, Z06CBG
Distribution pattern: US Nationwide distribution.
Derived failure modes
-
Unknown
Defective blocks may show cracks after sintering If cracks are unnoticed, restorations may fracture in the patient's mouth and require restoration