Device product
IPS e.max ZirCAD CER/in. Prime A2 C17/5 -A zirconium oxide block for the fabrication of fixed, full-contour restorations in anterior and posterior teeth. Article Number: 758438
Z-1705-2024
Product summary
- Event
- Event 94401
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 11330 units
- Official record key
device-enforcement:Z-1705-2024
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)07615208438666 (11)231117 (10)Z063MX (241)758438; (01)07615208438666 (11)231214 (10)Z067JH (241)758438; (01)07615208438666 (11)240105 (10)Z06B6Y (241)758438; (01)07615208438666 (11)240118 (10)Z06D4N (241)758438 Batch No. Z063MX, Z067JH, Z067J9, Z06B6Y, Z06D4N
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