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
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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.
Brand
Jeneric/Pentron
Lot Codes / Batch Numbers
Lot Number 191691
Products Sold
Lot Number 191691
Jeneric/Pentron is recalling TempSpan Dual-Cure Temporary Crown and Bridge Material, PART NUMBER N69AD, The intended use of thi due to Pentron Clinical Technologies LLC received two (2) complaints alleging that the TempSpan Dual-Cure Temporary Crown and Bridge Material was not setting. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026