Device product
IPS e.max ZirCAD CER/in. Prime A1 C17/5 - A zirconium oxide block for the fabrication of fixed, full-contour restorations in anterior and posterior teeth. Article Number: 758437
Z-1704-2024
Product summary
- Event
- Event 94401
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 7445 units
- Official record key
device-enforcement:Z-1704-2024
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)07615208438673 (11)231214 (10)Z067J5 (241)758437; (01)07615208438673 (11)231214 (10)Z067J6 (241)758437; (01)07615208438673 (11)240112 (10)Z06CBD (241)758437; (01)07615208438673 (11)240112 (10)Z06CBF (241)758437 Batch No. Z067J5, Z067J6, Z06CBD, Z06CBF
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