FDA-Device2024-05-08Class II
IPS e.max ZirCAD CER/in. Prime B1 C17/5 -A zirconium oxide block for the fabrication of fixed, full-contour restorations in anterior and posterior teeth. Article Number: 758441
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
4080 units
Manufactured in
BEDERSRASSE, LIECHTSTEIN, Germany
Products
IPS e.max ZirCAD CER/in. Prime B1 C17/5 -A zirconium oxide block for the fabrication of fixed, full-contour restorations in anterior and posterior teeth. Article Number: 758441
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1707-2024Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief