IVOCLAR VIVADENT AG: 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

Hazard

Defective blocks may show cracks after sintering If cracks are unnoticed, restorations may fracture in the patient's mouth and require restoration

Details from the source

Reason for recall: Defective blocks may show cracks after sintering If cracks are unnoticed, restorations may fracture in the patient's mouth and require restoration Distribution: US Nationwide distribution. Quantity: 7445 units Lot/code info: 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

UPC codes

07615208438673

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.