Recall Z-2265-2015— Ivoclar Vivadent, Inc.

Name: FDA recall Z-2265-2015
Creator: U.S. Food and Drug Administration
Published: 2015-07-09

Class II · Terminated

Class II FDA medical device recall by Ivoclar Vivadent, Inc., initiated 2015-07-09, terminated 2016-05-27. It names one FDA 510(k) clearance: K012174. 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. Reason: 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..

Recalling firm: Ivoclar Vivadent, Inc.
Classification: Class II
Status: Terminated
Initiated: 2015-07-09
Terminated: 2016-05-27
Firm location: Buffalo, NY, United States

510(k) clearances named in this recall

1 on FDA's record

K012174 — ERIS LAYERING MATERIALSIvoclar North America, Inc.·cleared 2001-08-27

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.