Recall Z-0717-2017— Ivoclar Vivadent, Inc.
Class II · Terminated
Class II FDA medical device recall by Ivoclar Vivadent, Inc., initiated 2016-11-09, terminated 2018-06-18. It names one FDA 510(k) clearance: K083739. Product: Virtual XD Refill Light Body Fast Set Wash Material, 2X50 ml, REF #/Product Code 646461, Rx ONLY -- product Usage: Dental impression material. Reason: The firm received complaints claiming the dental material failed to set up. As the dental material ages, the set time may increase..
- Recalling firm
- Ivoclar Vivadent, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2016-11-09
- Terminated
- 2018-06-18
- Firm location
- Amherst, NY, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Virtual XD Refill Light Body Fast Set Wash Material, 2X50 ml, REF #/Product Code 646461, Rx ONLY -- product Usage: Dental impression material
Reason for recall
The firm received complaints claiming the dental material failed to set up. As the dental material ages, the set time may increase.
Data sourced from openFDA. This site is unofficial and independent of the FDA.