Device product
Virtual XD Refill Light Body Fast Set Wash Material, 2X50 ml, REF #/Product Code 646461, Rx ONLY -- product Usage: Dental impression material
Z-0717-2017
Product summary
- Event
- Event 75620
- Status
- Terminated
- Classification
- Class II
- Quantity
- US: 4659 units, Canada: 729 units
- Official record key
device-enforcement:Z-0717-2017
Official wording
Reason: The firm received complaints claiming the dental material failed to set up. As the dental material ages, the set time may increase.
Code information: Lot No./Expiration Date: UL2395/June 28, 2018; UL2293/Dec 31, 2017; UL2222/Aug 28, 2017; UL2220/July 28, 2017; TL4121/ Mar 28, 2017
Distribution pattern: Worldwide Distribution - US Nationwide and the countries of Canada and Australia
Derived failure modes
-
Unknown
The firm received complaints claiming the dental material failed to set up. As the dental material ages, the set time may increase.