FDA Medical Device Recalls (openFDA)
Lang Dental Mfg Co, Inc.: 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
- Recall number
- Z-1041-04
- 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
- Status
- Terminated
- Initiated
- 2004-06-07
- Posted
- 2004-07-20
- Terminated
- 2004-09-20
- Reason
- The dental acrylic resin powders are contaminated with small black particles believed to be polyethylene.
- 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
- 402 units
- Distribution
- Nationwide
- Lot, serial or model codes
- 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
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- EBG
- Firm FEI
- 1417322
- Firm city
- Wheeling
- Firm state
- IL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28