FDA Medical Device Recalls (openFDA)
Lang Dental Mfg Co, Inc.: Jet Denture Repair Acryulic, fast curing denture repair resin; Lang Dental Manufacturing Co., Inc., Wheeling, IL 60090-0969; product code 1220, 100 gram plastic squeeze bottle and product code 1223 100 gram plastic squeeze bottle, professional package
- Recall number
- Z-1043-04
- Recalling firm
- Lang Dental Mfg Co, Inc.
- Product
- Jet Denture Repair Acryulic, fast curing denture repair resin; Lang Dental Manufacturing Co., Inc., Wheeling, IL 60090-0969; product code 1220, 100 gram plastic squeeze bottle and product code 1223 100 gram plastic squeeze bottle, professional package
- 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
- 27 units
- Distribution
- Nationwide
- Lot, serial or model codes
- product code 1220, box lot 1220-4023, bottle lot 60274005/04AB - clear; product code 1223, box lot 1223-4024, bottle lot 60274005/04AB -clear and box lot 1223-4025, bottle lot 12163001/01AN - meharry
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- EBI
- 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