Recall Z-0376-2014— Ivoclar Vivadent, Inc.

Name: FDA recall Z-0376-2014
Creator: U.S. Food and Drug Administration
Published: 2013-09-23

Class II · Terminated

Class II FDA medical device recall by Ivoclar Vivadent, Inc., initiated 2013-09-23, terminated 2016-05-27. It names one FDA 510(k) clearance: K093744. Product: ExciTE F DSC Soft touch Single Dose, Dual-curing Regular Ref. 50 dental adhesive for restorations. Reason: Ivoclar Vivadent, Inc. is recalling a lot of ExciTE F DSC Dental Adhesive found to produce a blue green discoloration when used in combination with cements..

Recalling firm: Ivoclar Vivadent, Inc.
Classification: Class II
Status: Terminated
Initiated: 2013-09-23
Terminated: 2016-05-27
Firm location: Buffalo, NY, United States

510(k) clearances named in this recall

1 on FDA's record

K093744 — EXCITE F AND EXCITE DSCIvoclar Vivadent, Inc.·cleared 2010-03-10

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

ExciTE F DSC Soft touch Single Dose, Dual-curing Regular Ref. 50 dental adhesive for restorations

Reason for recall

Ivoclar Vivadent, Inc. is recalling a lot of ExciTE F DSC Dental Adhesive found to produce a blue green discoloration when used in combination with cements.

Data sourced from openFDA. This site is unofficial and independent of the FDA.