FDA-Device2016-12-14Class II

Virtual XD Refill Light Body Regular Set Wash Material, 2X50 ml, REF #/Product Code 646462, 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: 1867 units, Canada: 465 units
Manufactured in
175 Pineview Dr, N/A, Amherst, NY, United States
Products
Virtual XD Refill Light Body Regular Set Wash Material, 2X50 ml, REF #/Product Code 646462, Rx ONLY -- Product Usage: Dental impression material

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0718-2017

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