Z-1840-2020Class II

Ivoclar Vivadent IPS e.max ZirCAD CER/inLab Start.Kit LT - ceramic for dental use, intended for IPS e.max...

Name: Z-1840-2020 Ivoclar Vivadent IPS e.max ZirCAD CER/inLab Start.Kit LT - ceramic for dental use, intended for IPS e.max...
Creator: Ivoclar Vivadent AG
Published: 2020-04-13
License: https://open.fda.gov/license/

Ivoclar Vivadent, Inc. / initiated 2020-04-13 / Terminated / root cause: manufacturing process

FDA source

Ivoclar Vivadent AG began a recall of 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... on 2020-04-13. FDA classified it as Class II and gives the reason as "Restorations crack during the sintering process". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1840-2020
Classification: Class II
Status: Terminated
Initiated: 2020-04-13
Posted: 2020-05-01
Terminated: 2021-01-22
Recalling firm: Ivoclar Vivadent, Inc.
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
Product code: EIH Powder, Porcelain
Reason for recall: Restorations crack during the sintering process.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Ivoclar Vivadent issued notification via email to distributors on 4/13/20 via email and email and priority mail to Dentists, labs on by 4/20/20. Letter states reason for recall, health risk and action to take: Actions to be taken: 1. Check your stock and immediately segregate any material marked with the affected lot numbers. 2. Discard product. 3. Complete, sign and return the attached acknowledgement form and email to [email protected]. 4. Credit will be issued for all returned acknowledgment forms Questions contact Ivoclar Vivadent Customer Service at 800-533-6825 or your Patterson representative.
Quantity in commerce: 6 units
Distribution: US Nationwide distribution.
Product codes and lots: Lot Numbers: Z0007Z, Z000KK, Y49356, Z006HV

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1840-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1837-2020	Class II	Terminated	Voluntary: Firm initiated	2020-05-13	2020-05-01
Z-1838-2020	Class II	Terminated	Voluntary: Firm initiated	2020-05-13	2020-05-01
Z-1839-2020	Class II	Terminated	Voluntary: Firm initiated	2020-05-13	2020-05-01
Z-1840-2020	Class II	Terminated	Voluntary: Firm initiated	2020-05-13	2020-05-01

Product code EIH

K051705Class IIIps E.max Cad/ips E.max ZircadIvoclar Vivadent, Inc. / cleared 2005-10-14

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)