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U.S. Department of Health and Human Services

Class 2 Device Recall Peak SE Primer

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 Class 2 Device Recall Peak SE Primersee related information
Date Initiated by FirmJune 01, 2022
Create DateJuly 12, 2022
Recall Status1 Completed
Recall NumberZ-1368-2022
Recall Event ID 90434
510(K)NumberK063558 
Product Classification Agent, tooth bonding, resin - Product Code KLE
ProductPeak Universal Bond Self-Etch Bottle Kit, Part: 4541; Peak Universal Bond Self-Etch Intro Kit, Part: 4554; Peak SE Primer 4pk Refill, Part: 5135; Peak Universal Bond Sample SE, Part: S4554. For use in light-curing dental bonding procedures.
Code Information REF/ UDI-DI/ Lot: 4541/ 00883205104274/ BLRCR, BM1Y7, BM9G3; 4554/ 00883205104281/ BLSGH, BM578, BN449; 5135/ 00883205104311/ BLX3F, BLSGM, BLXSG, BLXW4, BM34M, BM784, BM9KB, BMJVK, BMTZM; S4554/ 00883205102065/ BLRJJ, BM1NH
Recalling Firm/
Manufacturer		 Ultradent Products, Inc.
505 W 10200 S
South Jordan UT 84095-3800
For Additional Information Contact
801-553-4194
Manufacturer Reason
for Recall		SE primer may be missing some or all of the resin portion of the chemistry. The absence of resin may impact bond strength and restoration while using the primer.
FDA Determined
Cause 2		Device Design
ActionOn 06/01/22, recall notices were mailed to customers who were asked to do the following: 1) Discard all primers inside affected devices. 2) Complete and return the recall notice response form. Customers with questions regarding product credit may call Customer Service at 1-888-2301420. Customers with questions or concerns related to the primer can contact Customer Concerns at 801-553-4139.
Quantity in Commerce1331 Kits (5009 Syringes)
DistributionWorldwide distribution - US Nationwide distribution in the states of Florida, Michigan, Nevada, Washington, Colorado, Virginia, Puerto Rico, Wisconsin, Iowa, Tennessee, Arkansas, Minnesota, Wyoming, Maine and the countries of Kuwait, Italy, France, Canada, Spain, Malaysia, Russia, Greece.
Total Product Life CycleTPLC 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.
510(K) Database510(K)s with Product Code = KLE
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