Device product
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
Z-1837-2020
Product summary
- Event
- Event 85450
- Status
- Terminated
- Classification
- Class II
- Quantity
- 9 units
- Official record key
device-enforcement:Z-1837-2020
Official wording
Reason: Restorations crack during the sintering process.
Code information: Lot Number: Y48711
Distribution pattern: US Nationwide distribution.
Derived failure modes
-
Unknown
Restorations crack during the sintering process.