Z-2265-2015Class II

IPS Empress Universal Glaze Spray 270 mL, Product Code/Model/Catalog Number 609432AN, Rx only. Porcelain...

Name: Z-2265-2015 IPS Empress Universal Glaze Spray 270 mL, Product Code/Model/Catalog Number 609432AN, Rx only. Porcelain...
Creator: Ivoclar Vivadent, Inc.
Published: 2015-07-09
License: https://open.fda.gov/license/

Ivoclar Vivadent, Inc. / initiated 2015-07-09 / Terminated / root cause: manufacturing process

FDA source

Ivoclar Vivadent, Inc. began a recall of IPS Empress Universal Glaze Spray 270 mL, Product Code/Model/Catalog Number 609432AN, Rx only. Porcelain glaze spray used in the fabrication of dental... on 2015-07-09. FDA classified it as Class II and gives the reason as "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". 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-2265-2015
Classification: Class II
Status: Terminated
Initiated: 2015-07-09
Posted: 2015-07-27
Terminated: 2016-05-27
Recalling firm: Ivoclar Vivadent, Inc.
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
Product code: EIH Powder, Porcelain
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.
Root cause tag: manufacturing process
FDA root cause: 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.
Product codes and lots: Batch U15124

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2265-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2265-2015	Class II	Terminated	Voluntary: Firm initiated	2015-08-05	2015-07-27

Product code EIH

K012174Class IIEris Layering MaterialsIvoclar North America, Inc. / cleared 2001-08-27

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)