Recalls for Cement, Dental

Due to an error in the manufacturing process, it is possible that an incorrect plunger has been fitted to some capsules. This plunger does not contain the correct reactive component for Ionolux. When these capsules are activated, curing is significantly delayed and incomplete. Processing according to the instructions for use is not possible.

Due to an error in the manufacturing process, it is possible that an incorrect plunger has been fitted to some capsules. This plunger does not contain the correct reactive component for Ionolux. When these capsules are activated, curing is significantly delayed and incomplete. Processing according to the instructions for use is not possible.

Products were stored outside of labeled temperature requirements.

Product is labeled with an incorrect expiration date.

Affected product was not appropriately stored in temperature-controlled areas between April 30, 2022 - June 10, 2022.

The recall was initiated because Pentron Clinical has confirmed that the TempSpan Temporary Cement may have black plastic material on the surface of the paste, and it may set faster than specified.

The recall was initiated because Pentron Clinical has confirmed that the Breeze Self-Adhesive Resin Cement exhibits faster than expected gel and set times. If the work time is exceeded when using this material, it could possibly result in inadequate bond strength.

The specific lots of Maxcem Elite Refill Kit appear not to be authentic.

The firm initiated a recall because the product sets faster than specified in the "Directions for Use" and in release specifications.

The resin material separates when the product is extruded from the syringe. Although there are no safety issues related with this situation, please refrain from using the affected product.

Pentron is voluntarily recalling the Breeze Self Adhesive Resin Cement because it was discovered that there may be a curing problem that may cause cemented crowns to fall off after use of the product.

The recall was initiated because the catalyst portion of the syringe may have polymerized, therefore making the product unusable.

During product stability testing, Bisco determined that after 15 months of storage, BISCEM Self-Adhesive Luting Cement used in self-cure mode only without light-curing may take longer than specified to set, resulting in reduced bond strength. Bisco also determined that product component(s) may thicken slightly over time.

During product stability testing, Bisco determined that after 15 months of storage, BISCEM Self-Adhesive Luting Cement used in self-cure mode only without light-curing may take longer than specified to set, resulting in reduced bond strength. Bisco also determined that product component(s) may thicken slightly over time.

Low Bonding performance: The affected lots of product may not activate properly, which may cause lower than expected bonding performance (due to a low level of chemical cure initiator in the lots manufactured)

An issue within production process used to package trial kits let to the inclusion of the incorrect bonding agent for the kit. Use of the incorrect bonding agent may lead to increased risk of bond failures.