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U.S. Department of Health and Human Services

Class 3 Device Recall Jet Tooth Shade Powder

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  Class 3 Device Recall Jet Tooth Shade Powder see related information
Date Initiated by Firm June 07, 2004
Date Posted July 20, 2004
Recall Status1 Terminated 3 on September 20, 2004
Recall Number Z-1041-04
Recall Event ID 29304
Product Classification Crown And Bridge, Temporary, Resin - Product Code EBG
Product Jet Tooth Shade Powder, a fast curing temporary crown and bridge acrylic; product code 1410, Net Wt. 45 g (2 oz.) plastic squeeze bottles and product code 1420, Net Wt. 100 g (4 oz.) plastic squeeze bottles; Lang Dental Manufacturing Co., Inc., Wheeling, IL 60090-0969
Code Information 2 oz. bottles:  box ot 1410-4117, bottle lot 60074003/04AD - shade 62;  box lot 1410-4120, bottle lot 60044001/01AE - shade 59;  box lot 1410-4122, bottle lot 60123005/03AF - shade 69; 4 oz. bottles:  box lot 1420-4118, bottle lot 60083006/04AK - shade 65;  box lot 1420-4119, bottle lot 60024001/01AJ - shade LI;  box lot 1420-4120, bottle lot 60133003/03AJ - shade 77;  box lot 1420-4123, bottle lot 60143005/03AK - shade 81;  box lot 1420-4126, bottle lot 60103002/02AD - shade 67;  box lot 1420-4128, bottle lot 60024001/01AL - shade LI;  box lot 1420-4130, bottle lot 60063002/02AU - shade 61;  box lot 1420-4131, bottle lot 60074003/04AE - shade 62;  box lot 1420-4134, bottle lot 60173001/01BU - shade C4;  box lot 1420-4135, bottle lot 60084001/01AC - shade 65
Recalling Firm/
Manufacturer
Lang Dental Mfg Co, Inc.
175 Messner Dr
Wheeling IL 60090-6433
For Additional Information Contact Ms. Joanne B. Lang
800-222-5264 Ext. 25
Manufacturer Reason
for Recall
The dental acrylic resin powders are contaminated with small black particles believed to be polyethylene.
FDA Determined
Cause 2
Other
Action Lang Dental sent recall letters dated 6/7/04 to their direct accounts, informing them of the contamination of the acrylic resin powders with the black particles and requesting the return of any existing inventory of the affected lots of product for replacement. Distributors were requested to sub-recall the products from their accounts. Follow-up letters were sent to the accounts on 6/14/04, clarifying the lot numbers affected to include both the lot number on the box and the lot number on the bottom of the squeeze bottles affected.
Quantity in Commerce 402 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.
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