Recall Z-1839-2020— Ivoclar Vivadent AG

Name: FDA recall Z-1839-2020
Creator: U.S. Food and Drug Administration
Published: 2020-04-13

Class II · Terminated

Class II FDA medical device recall by Ivoclar Vivadent AG, initiated 2020-04-13, terminated 2021-01-22. It names one FDA 510(k) clearance: K051705. Product: 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. Reason: Restorations crack during the sintering process..

Recalling firm: Ivoclar Vivadent AG
Classification: Class II
Status: Terminated
Initiated: 2020-04-13
Terminated: 2021-01-22
Firm location: Schaan, N/A, Liechtenstein

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

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

Reason for recall

Restorations crack during the sintering process.

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