Reported Aug 5, 2015 · Terminated
IPS Empress Universal Glaze Spray 270 mL, Product Code/Model/Catalog Number 609432AN, Rx only. Porcelain glaze spray…
Ivoclar Vivadent, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Ivoclar Vivadent, Inc. · 175 Pineview Dr · Buffalo, NY · 14228-2231
Is this the product you have?
- 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
- Lot codes and dates
- Batch U15124
- Amount recalled
- Domestic: 27 units
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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