Z-0482-2010

TempSpan Dual-Cure Temporary Crown and Bridge Material, PART NUMBER N69AD, The intended use of this device is...

Name: Z-0482-2010 TempSpan Dual-Cure Temporary Crown and Bridge Material, PART NUMBER N69AD, The intended use of this device is...
Creator: Jeneric/Pentron
Published: 2009-10-22
License: https://open.fda.gov/license/

Jeneric/Pentron, Inc. / initiated 2009-10-22 / Terminated / root cause: manufacturing process

FDA source

Jeneric/Pentron began a recall of 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... on 2009-10-22. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0482-2010
Status: Terminated
Initiated: 2009-10-22
Posted: 2009-12-03
Terminated: 2012-07-19
Recalling firm: Jeneric/Pentron, Inc.
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.
Product code: EBG Crown And Bridge, Temporary, Resin
Reason for recall: 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 tag: manufacturing process
FDA 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 in commerce: 58 units
Distribution: Nationwide
Product codes and lots: Lot Number 191691

Product code EBG

K021457Class IIFlex Span Temporary Crown & Bridge MaterialPentron Corp. / cleared 2002-08-01

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)