FDA Medical Device Recalls (openFDA)
Jeneric/Pentron: 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.
- Recall number
- Z-0482-2010
- Recalling firm
- Jeneric/Pentron
- 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.
- Status
- Terminated
- Initiated
- 2009-10-22
- Posted
- 2009-12-03
- Terminated
- 2012-07-19
- Reason
- 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.
- Root cause
- 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
- 58 units
- Distribution
- Nationwide
- Lot, serial or model codes
- Lot Number 191691
- 510(k) numbers
- ["K021457"]
- PMA numbers
- not on file
- Product code
- EBG
- Firm FEI
- 3002803083
- Firm city
- Wallingford
- Firm state
- CT
- 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