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Recall Observatory FDA recall evidence

Device product

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

Z-0376-2014

September 23, 2013

Class II

Product summary

Firm
Ivoclar Vivadent, Inc.
Event
Event 66359
Status
Terminated
Classification
Class II
Quantity
63 refill packs (50 single use applications per refill)
Official record key
device-enforcement:Z-0376-2014

Official wording

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.

Code information: Product Code 630378AN; Lot Number: R59595; Expiration date of 3 January 2015

Distribution pattern: US Distribution: including states of PA, WA, WI, NY, LA, TX, NJ, CA, OR, IA, SC, IN, IL, and AZ.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.