FDA-Device2024-05-08Class II

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

IVOCLAR VIVADENT AG
Hazard

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

Sold states
US Nationwide distribution.
Affected count
7445 units
Manufactured in
BEDERSRASSE, LIECHTSTEIN, Germany
Products
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

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1704-2024

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