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U-Cem Premium
VERICOM CO., LTD. · Model UP109-AC00 · UDI-DI 08809254457330
EMA
Prescription
10
510(k) clearances
1,630
Adverse events
16
Recalls
147
Facilities
Description
Self-Adhesive Universal Resin Cement; Auto-mix 9g(Clear)X1cartridge, mixing tipX10ea, intraoral tipX10ea
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2024-01-25 | Voco GmbH | 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 componen |
| 2024-01-25 | Voco GmbH | 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 componen |
| 2023-10-04 | Family Dollar Stores, Llc. | Products were stored outside of labeled temperature requirements. |
| 2023-02-01 | Preat Corp | Product is labeled with an incorrect expiration date. |
| 2022-06-23 | Family Dollar Stores, Llc. | Affected product was not appropriately stored in temperature-controlled areas between April 30, 2022 - June 10, 2022. |
| 2020-02-25 | Kerr/Pentron, DBA Kerr Corporation and Pentron Clinical | 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 incre |
| 2011-11-10 | Henry Schein, Inc. | The specific lots of Maxcem Elite Refill Kit appear not to be authentic. |
| 2011-07-08 | Kerr/pentron Dba Kerr Corporation And Pentron Clinical | 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 |
| 2011-03-17 | Kerr/pentron Dba Kerr Corporation And Pentron Clinical | The firm initiated a recall because the product sets faster than specified in the "Directions for Use" and in release specifications. |
| 2011-03-03 | Kerr Corporation | 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 faste |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.