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Ivoclar Vivadent, Inc. recalls IPS Empress Universal Glaze Spray 270 mL, Product Code/Model/Catalog Number 609432AN, Rx only. Porcelain glaze spray u
Recalled August 5, 2015 · FDA recall Z-2265-2015 · Ivoclar Vivadent
Hazard
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 Class II
Units
Domestic: 27 units
Sold at
US Distribution in the states of: PA, IN, IA and SC.
Description
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.
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
Manufacturer(s)
Ivoclar Vivadent, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →