RegWardenFDA facility compliance records
Recall

Class II — IVOCLAR VIVADENT AG

Recalling firmIVOCLAR VIVADENT
Registered facilityView this company's 11 registered facilities → (openFDA recall records do not name a specific facility)
ClassificationClass II
StatusOngoing
ReasonDefective blocks may show cracks after sintering If cracks are unnoticed, restorations may fracture in the patient's mouth and require restoration
ProductIPS e.max ZirCAD CER/in. Prime A2 C17/5 -A zirconium oxide block for the fabrication of fixed, full-contour restorations in anterior and posterior teeth. Article Number: 758438
Quantity11330 units
DistributionUS Nationwide distribution.
Initiated2024-04-05
Classified2024-04-30
Recall numberZ-1705-2024
InitiationVoluntary: Firm initiated

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)

Cite this record

RegWarden. “Class II recall — IVOCLAR VIVADENT AG (Z-1705-2024).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/94401/

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