Device product
Virtual XD Test Pack Heavy/Light Fast Set, 2 x 50 ml, REF #/Product Code 646469, Rx ONLY -- Product Usage: Dental impression material
Z-0719-2017
Product summary
- Event
- Event 75620
- Status
- Terminated
- Classification
- Class II
- Quantity
- US: 2090 units, Canada: 331 units, Australia: 465 units
- Official record key
device-enforcement:Z-0719-2017
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: TL4095/Jan 15, 2017; TL4094/Jan 15, 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.