FDA-Device2016-12-14Class II
Virtual XD Test Pack Heavy/Light Fast Set, 2 x 50 ml, REF #/Product Code 646469, Rx ONLY -- Product Usage: Dental impression material
Ivoclar Vivadent, Inc.
Hazard
The firm received complaints claiming the dental material failed to set up. As the dental material ages, the set time may increase.
Sold states
Worldwide Distribution - US Nationwide and the countries of Canada and Australia
Affected count
US: 2090 units, Canada: 331 units, Australia: 465 units
Manufactured in
175 Pineview Dr, N/A, Amherst, NY, United States
Products
Virtual XD Test Pack Heavy/Light Fast Set, 2 x 50 ml, REF #/Product Code 646469, Rx ONLY -- Product Usage: Dental impression material
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0719-2017Don't want to check this manually?
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