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U.S. Department of Health and Human Services

Class 2 Device Recall FLEX SPAN TEMPORARY CROWN & BRIDGE MATERIAL

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  Class 2 Device Recall FLEX SPAN TEMPORARY CROWN & BRIDGE MATERIAL see related information
Date Initiated by Firm October 22, 2009
Date Posted December 03, 2009
Recall Status1 Terminated 3 on July 19, 2012
Recall Number Z-0482-2010
Recall Event ID 53673
510(K)Number K021457  
Product Classification Temporary crown and bridge resin - Product Code EBG
Product TempSpan Dual-Cure Temporary Crown and Bridge Material, PART NUMBER N69AD,

The intended use of this device is to make a temporary prosthesis, such as a crown or bridge, for use until a permanent restoration is fabricated.
Code Information Lot Number 191691
Recalling Firm/
Manufacturer		 Jeneric/Pentron
68 N Plains Industrial Rd
Wallingford CT 06492
Manufacturer Reason
for Recall		 Pentron Clinical Technologies LLC received two (2) complaints alleging that the TempSpan Dual-Cure Temporary Crown and Bridge Material was not setting. Investigation of product in inventory was conducted and it was confirmed that some of the bottles had been mispackaged with an incorrect catalyst.
FDA Determined
Cause 2		 Employee error
Action The recall customer notification was initiated on October 22, 2009 with the firm forwarding an urgent medical device letter with recall return form via USPS first class mail to the affected consignees. The letter informed the consignees of the reason for recall and instructed them to return any used or unused product of the affected lot. The firm provided an 800 number for the consignees to call to arrange for product return and replacement.
Quantity in Commerce 58 units
Distribution 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 = EBG and Original Applicant = PENTRON CORP.
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