Z-0376-2014Class II

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

Name: Z-0376-2014 ExciTE F DSC Soft touch Single Dose, Dual-curing Regular Ref. 50 dental adhesive for restorations
Creator: Ivoclar Vivadent, Inc.
Published: 2013-09-23
License: https://open.fda.gov/license/

Ivoclar Vivadent, Inc. / initiated 2013-09-23 / Terminated / root cause: manufacturing process

FDA source

Ivoclar Vivadent, Inc. began a recall of ExciTE F DSC Soft touch Single Dose, Dual-curing Regular Ref. 50 dental adhesive for restorations on 2013-09-23. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0376-2014
Classification: Class II
Status: Terminated
Initiated: 2013-09-23
Posted: 2013-11-21
Terminated: 2016-05-27
Recalling firm: Ivoclar Vivadent, Inc.
Product: ExciTE F DSC Soft touch Single Dose, Dual-curing Regular Ref. 50 dental adhesive for restorations
Product code: MZW Dental Cement W/Out Zinc-Oxide Eugenol As An Ulcer Covering For Pain Relief
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.
Root cause tag: manufacturing process
FDA root cause: Material/Component Contamination
Action: The firm, Ivoclar Vivadent, Inc., sent an "URGENT MEDICAL DEVICE RECALL" letter dated September 19, 2013 via first class mail to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to check your stock and segregate any material marked batch R59595; contact the Ivoclar Vivadent Customer Service at 800-533-6825 as soon as possible between the hours of 9:00am and 7:00pm EST Monday through Friday and a representative will arrange to have your stock replaced; both unopened and opened packages can be returned; and complete and return the Medical Device Recall Return Response Acknowledgment and Receipt Form. Please communicate locally with Ivoclar Vivadent Customer Service at 800-533-6825 for any questions.
Quantity in commerce: 63 refill packs (50 single use applications per refill)
Distribution: US Distribution: including states of PA, WA, WI, NY, LA, TX, NJ, CA, OR, IA, SC, IN, IL, and AZ.
Product codes and lots: Product Code 630378AN; Lot Number: R59595; Expiration date of 3 January 2015

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0376-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0376-2014	Class II	Terminated	Voluntary: Firm initiated	2013-11-27	2013-11-21

Product code MZW

K093744Class IIExcite F and Excite DscIvoclar Vivadent, Inc. / cleared 2010-03-10

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)