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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 Spray see related information
Date Initiated by Firm July 09, 2015
Date Posted July 27, 2015
Recall Status1 Terminated 3 on May 27, 2016
Recall Number Z-2265-2015
Recall Event ID 71636
510(K)Number K012174  
Product Classification Powder, porcelain - Product Code EIH
Product IPS 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
Recalling Firm/
Manufacturer		 Ivoclar Vivadent, Inc.
175 Pineview Dr
Buffalo NY 14228-2231
For Additional Information Contact Donna 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
Action Ivoclar 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 Commerce Domestic: 27 units
Distribution US Distribution in the states of: PA, IN, IA and SC.
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 NORTH AMERICA, INC.
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