RegWardenFDA facility compliance records
Recall

Class II — Ivoclar Vivadent, Inc.

Recalling firmIVOCLAR VIVADENT
Registered facilityView this company's 11 registered facilities → (openFDA recall records do not name a specific facility)
ClassificationClass II
StatusTerminated
ReasonIvoclar 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.
ProductExciTE F DSC Soft touch Single Dose, Dual-curing Regular Ref. 50 dental adhesive for restorations
Quantity63 refill packs (50 single use applications per refill)
DistributionUS Distribution: including states of PA, WA, WI, NY, LA, TX, NJ, CA, OR, IA, SC, IN, IL, and AZ.
Initiated2013-09-23
Classified2013-11-21
Terminated2016-05-27
Recall numberZ-0376-2014
InitiationVoluntary: Firm initiated

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)

Cite this record

RegWarden. “Class II recall — Ivoclar Vivadent, Inc. (Z-0376-2014).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/66359/

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