FDA-Device2015-08-05Class II
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
Ivoclar Vivadent, Inc.
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.
Sold states
US Distribution in the states of: PA, IN, IA and SC.
Affected count
Domestic: 27 units
Manufactured in
175 Pineview Dr, N/A, Buffalo, NY, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2265-2015Don't want to check this manually?
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