Recall Z-0718-2017— Ivoclar Vivadent, Inc.

Name: FDA recall Z-0718-2017
Creator: U.S. Food and Drug Administration
Published: 2016-11-09

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 Regular Set Wash Material, 2X50 ml, REF #/Product Code 646462, 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 record

K083739 — HYDRORISE AND HYDROSYSTEMZhermack S.P.A.·cleared 2009-03-26

K-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 Regular Set Wash Material, 2X50 ml, REF #/Product Code 646462, 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.