FDA-Device2016-12-14Class II
Virtual XD Refill Light Body Fast Set Wash Material, 2X50 ml, REF #/Product Code 646461, 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: 4659 units, Canada: 729 units
Manufactured in
175 Pineview Dr, N/A, Amherst, NY, United States
Products
Virtual XD Refill Light Body Fast Set Wash Material, 2X50 ml, REF #/Product Code 646461, Rx ONLY -- product Usage: Dental impression material
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0717-2017Don't want to check this manually?
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