FDA-Device2020-05-13Class II

Ivoclar Vivadent IPS e.max ZirCAD CER/inLab LT A1 C17/5 -ceramic for dental use, intended for IPS e.max ZirCAD presintered yttrium oxide-stabilized zirconium oxide blocks for the CAD/CAM technology Product Number: 686193

Ivoclar Vivadent AG
Hazard

Restorations crack during the sintering process.

Sold states
US Nationwide distribution.
Affected count
9 units
Manufactured in
Benderer Strasse 2, N/A, Schaan, N/A, Liechtenstein
Products
Ivoclar Vivadent IPS e.max ZirCAD CER/inLab LT A1 C17/5 -ceramic for dental use, intended for IPS e.max ZirCAD presintered yttrium oxide-stabilized zirconium oxide blocks for the CAD/CAM technology Product Number: 686193

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1837-2020

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