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FDAFDA · Food and drugs·Recall number Z-0376-2014

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

Published November 27, 2013 · Recall initiated: September 23, 2013

Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.

What's the hazard

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.

What to do

Voluntary: Firm initiated · Telephone

Recall details

Manufacturer
Ivoclar Vivadent, Inc.
Distributor
US Distribution: including states of PA, WA, WI, NY, LA, TX, NJ, CA, OR, IA, SC, IN, IL, and AZ.
Lot
Product Code 630378AN; Lot Number: R59595; Expiration date of 3 January 2015
Risk classification
Class II
Area (FDA)
device
Country
United States

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