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U.S. Department of Health and Human Services

Class 2 Device Recall UltraSeal XT Plus Clear Refill

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  Class 2 Device Recall UltraSeal XT Plus Clear Refill see related information
Date Initiated by Firm November 17, 2016
Date Posted December 03, 2016
Recall Status1 Terminated 3 on June 05, 2017
Recall Number Z-0704-2017
Recall Event ID 75796
510(K)Number K993846  
Product Classification Sealant, pit and fissure, and conditioner - Product Code EBC
Product UltraSeal XT Plus Clear Refill. The package contains 4x 1.2 ml UltraSeal XT Plus.

Product Usage:
The UltraSeal XT Plus is used for prophylactic sealing of pits and fissures. It may also be used for micro restorative or initial layer of composite restorations.
Code Information Lot BD79T
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		 There was a labeling error with product, UltraSeal XT Plus Clear Refill, Part Number (PN) 565, Lot Number (Lot) BD79T. The package was mislabeled as PQ1, PN 641; while the barcode, IFU and products were labeled for UltraSeal XT Plus Clear Refill, PN 565, Lot BD79T.
FDA Determined
Cause 2		 Labeling mix-ups
Action Consignees notified via phone on 17Nov2016 and by letter on 22Nov2016 to identify and return products. Consignees with any questions regarding this field action can be sent to 801-553-4858 or 801-553-4220.
Quantity in Commerce 31
Distribution Worldwide Distribution - US Nationwide
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 = EBC and Original Applicant = ULTRADENT PRODUCTS, INC.
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