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U.S. Department of Health and Human Services

Class 2 Device Recall Peak SE Primer Refill

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  Class 2 Device Recall Peak SE Primer Refill see related information
Date Initiated by Firm May 24, 2012
Date Posted June 18, 2012
Recall Status1 Terminated 3 on August 15, 2012
Recall Number Z-1822-2012
Recall Event ID 62120
510(K)Number K063558  
Product Classification Agent, tooth bonding, resin - Product Code KLE
Product 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.
Code Information Lot number: B6Z4K.
Recalling Firm/
Ultradent Products, Inc.
505 W 10200 S
South Jordan UT 84095-3935
For Additional Information Contact
Manufacturer Reason
for Recall
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.
FDA Determined
Cause 2
Labeling mix-ups
Action Ultradent Products Inc. sent an "URGENT MEDICAL DEVICE RECALL" letter dated June 5, 2012 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. The letter instructs customers to discard any affected product from their 5135 kit. Customers were asked to complete and return a Recall Return Response form to the firm by fax at 801-553-4609.
Quantity in Commerce 172 kits (4 syringes per kit)
Distribution Worldwide Distribution.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = KLE and Original Applicant = ULTRADENT PRODUCTS, INC.