Recall Z-1705-2024— IVOCLAR VIVADENT AG

Name: FDA recall Z-1705-2024
Creator: U.S. Food and Drug Administration
Published: 2024-04-05

Class II · Ongoing

Class II FDA medical device recall by IVOCLAR VIVADENT AG, initiated 2024-04-05. It names one FDA 510(k) clearance: K051705. Product: IPS 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. Reason: Defective blocks may show cracks after sintering If cracks are unnoticed, restorations may fracture in the patient's mouth and require restoration.

Recalling firm: IVOCLAR VIVADENT AG
Classification: Class II
Status: Ongoing
Initiated: 2024-04-05
Firm location: LIECHTSTEIN, Germany

510(k) clearances named in this recall

1 on FDA's record

K051705 — IPS E.MAX CAD/IPS E.MAX ZIRCADIvoclar Vivadent, Inc.·cleared 2005-10-14

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

IPS 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

Reason for recall

Defective blocks may show cracks after sintering If cracks are unnoticed, restorations may fracture in the patient's mouth and require restoration

Data sourced from openFDA. This site is unofficial and independent of the FDA.