Device product
Ivoclar Vivadent IPS e.max ZirCAD CER/inLab Start.Kit LT - ceramic for dental use, intended for IPS e.max ZirCAD presintered yttrium oxide-stabilized zirconium oxide blocks for the CAD/ CAM technology Product Number: 686282EN
Z-1840-2020
Product summary
- Event
- Event 85450
- Status
- Terminated
- Classification
- Class II
- Quantity
- 6 units
- Official record key
device-enforcement:Z-1840-2020
Official wording
Reason: Restorations crack during the sintering process.
Code information: Lot Numbers: Z0007Z, Z000KK, Y49356, Z006HV
Distribution pattern: US Nationwide distribution.
Derived failure modes
-
Unknown
Restorations crack during the sintering process.