Device product
IPS e.max ZirCAD CER/in. Prime C2 C17/5- A zirconium oxide block for the fabrication of fixed, full-contour restorations in anterior and posterior teeth. Article Number: 758443
Z-1708-2024
Product summary
- Event
- Event 94401
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 2472 units
- Official record key
device-enforcement:Z-1708-2024
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)07615208438611 (11)231130 (10)Z065M1 (241)758443 Batch No.: Z065M1
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