Z-1041-04

Jet Tooth Shade Powder, a fast curing temporary crown and bridge acrylic; product code 1410, Net Wt. 45 g (2...

Name: Z-1041-04 Jet Tooth Shade Powder, a fast curing temporary crown and bridge acrylic; product code 1410, Net Wt. 45 g (2...
Creator: Lang Dental Mfg Co, Inc.
Published: 2004-06-07
License: https://open.fda.gov/license/

Lang Dental Mfg Co, Inc. / initiated 2004-06-07 / Terminated

FDA source

Lang Dental Mfg Co, Inc. began a recall of 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... on 2004-06-07. The reason FDA records is "The dental acrylic resin powders are contaminated with small black particles believed to be polyethylene". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1041-04
Status: Terminated
Initiated: 2004-06-07
Posted: 2004-07-20
Terminated: 2004-09-20
Recalling firm: Lang Dental Mfg Co, Inc.
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
Product code: EBG Crown And Bridge, Temporary, Resin
Reason for recall: The dental acrylic resin powders are contaminated with small black particles believed to be polyethylene.
FDA root cause: 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
Product codes and lots: 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

Product code EBG

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)