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U.S. Department of Health and Human Services

Class 2 Device Recall IPS Empress Universal Glaze Spray

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 Class 2 Device Recall IPS Empress Universal Glaze Spraysee related information
Date Initiated by FirmJuly 09, 2015
Date PostedJuly 27, 2015
Recall Status1 Terminated 3 on May 27, 2016
Recall NumberZ-2265-2015
Recall Event ID 71636
510(K)NumberK012174 
Product Classification Powder, porcelain - Product Code EIH
ProductIPS Empress Universal Glaze Spray 270 mL, Product Code/Model/Catalog Number 609432AN, Rx only. Porcelain glaze spray used in the fabrication of dental restorations
Code Information Batch U15124
FEI Number 1316092
Recalling Firm/
Manufacturer		 Ivoclar Vivadent, Inc.
175 Pineview Dr
Buffalo NY 14228-2231
For Additional Information ContactDonna Marie Hartnett, Esq.
716-691-2260
Manufacturer Reason
for Recall		Complaints were received of coarse particles in the glazed surface of IPS e.max Ceram restorations. A basic component of the glass contains a higher number of large grain sizes than usual.
FDA Determined
Cause 2		Nonconforming Material/Component
ActionIvoclar Vivadent sent an URGENT MEDICAL DEVICE RECALL Letter (dated 7/8/2015) and Response Form to affected customers via Certified Mail Return Receipt Request. The letter identified the affected product, problem and actions to be taken. Customers were instructed to notify dentists of the recall and request return of product. A notification letter was sent to dentists on 7/24/2015 requesting they destroy the product on hand (if any) and report back to Ivoclar Vivodent. For questions in the United States contact US Headquarters Ivoclar Vivadent Customer Services at 1-800-533-6825.
Quantity in CommerceDomestic: 27 units
DistributionUS Distribution in the states of: PA, IN, IA and SC.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = EIH
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