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U.S. Department of Health and Human Services

Class 2 Device Recall Ivoclar Vivadent

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  Class 2 Device Recall Ivoclar Vivadent see related information
Date Initiated by Firm April 13, 2020
Create Date May 01, 2020
Recall Status1 Terminated 3 on January 22, 2021
Recall Number Z-1838-2020
Recall Event ID 85450
510(K)Number K051705  
Product Classification Powder, porcelain - Product Code EIH
Product Ivoclar Vivadent IPS e.max ZirCAD CER/inLab LT A2 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: 686194
Code Information Lot Numbers: Y47472, Z000V0
Recalling Firm/
Manufacturer		 Ivoclar Vivadent AG
Benderer Strasse 2
Schaan Liechtenstein
Manufacturer Reason
for Recall		 Restorations crack during the sintering process.
FDA Determined
Cause 2		 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 Scott.Buchheit@pattersondental.com. 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 332
Distribution US Nationwide distribution.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = EIH and Original Applicant = IVOCLAR VIVADENT, INC.
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