FDA-Device2020-05-13Class II

Ivoclar Vivadent IPS e.max ZirCAD CER/inLab LT A3 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: 686195

Ivoclar Vivadent AG
Hazard

Restorations crack during the sintering process.

Sold states
US Nationwide distribution.
Affected count
639 units
Manufactured in
Benderer Strasse 2, N/A, Schaan, N/A, Liechtenstein
Products
Ivoclar Vivadent IPS e.max ZirCAD CER/inLab LT A3 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: 686195

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1839-2020

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