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U.S. Department of Health and Human Services

Enforcement Report - Week of June 27, 2012

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Event Detail

Event ID 62120
Product Type Devices
Status Ongoing
Recalling Firm Ultradent Products, Inc.
City South Jordan
State UT
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-05-24
Initial Firm Notification of
Consignee or Public
Letter
Distribution Pattern Worldwide Distribution.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Peak SE Primer Kits (4 syringes per kit) manufactured by Ultradent Products, Inc, South Jordan, UT, Self Etch Primer. The product is contained within prefilled, labeled syringes in a transparent plastic container identified with an aqua, red, orange, blue and black label with black and blue print writing. Product code: 5135, 872.3200 KLE, liquid and powder mixture is a syringe-in-a-syringe delivery system. The product is used for most bonding needs in restorative dentistry. Bonds chemical cure luting and chemical cure composites, namely PermaFlo DC. Peak SE does not require a separate etching step for quality adhesion. Peak SE is also conducive for bonding to: Dentin and enamel, porcelain, metal and composite. Lot number: B6Z4K. Class II Ultradent is recalling lot B6Z4K of Peak SE Primer as a result of a field complaint, dated May 10, 2012, stating that a syringe of Peak SE Primer was mislabeled as Peak LC Bond Resin. These products are used by Dental professionals for bonding needs in restorative dental procedures. 172 kits (4 syringes per kit) Z-1822-2012
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