Ivoclar Vivadent, Inc.: The firm received complaints claiming the dental material failed to set up. As the dental material ages, the set time may increase.

Agency Publication Date: December 7, 2016

Affected Products

Product: Virtual XD Refill Light Body Fast Set Wash Material, 2X50 ml, REF #/Product Code 646461, Rx ONLY -- product Usage: Dental impression material

Lot No./Expiration Date: UL2395/June 28, 2018; UL2293/Dec 31, 2017; UL2222/Aug 28, 2017; UL2220/July 28, 2017; TL4121/ Mar 28, 2017

Product: Virtual XD Refill Light Body Regular Set Wash Material, 2X50 ml, REF #/Product Code 646462, Rx ONLY -- Product Usage: Dental impression material

Lot No./Expiration Date: UL2221/July 28, 2017; TL4056/Nov 28, 2016

Product: Virtual XD Test Pack Heavy/Light Fast Set, 2 x 50 ml, REF #/Product Code 646469, Rx ONLY -- Product Usage: Dental impression material

Lot No./Expiration Date: TL4095/Jan 15, 2017; TL4094/Jan 15, 2017

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 75620

Status: Resolved

Manufacturer: Ivoclar Vivadent, Inc.

Manufactured In: United States

Units Affected: 3 products (US: 4659 units, Canada: 729 units; US: 1867 units, Canada: 465 units; US: 2090 units, Canada: 331 units, Australia: 465 units)

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Sources: FDA iRES · Raw API Response

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