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Solventum™ Filtek™
Solventum US LLC · Model 6125S · UDI-DI 00197998345166
EBF
Prescription
10
510(k) clearances
961
Adverse events (1 deaths)
71
Recalls
207
Facilities
Description
Solventum™ Filtek™ Easy Match Flowable Restorative, Sample, 6125S, 1 g, Syringe, N, 1/KT, 10/CS
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-07-09 | Henry Schein Inc. | Specific lots were distributed in the US with incorrect packaging and Instructions for Use (IFU) from the U.S. FDA-cleared device. |
| 2026-07-09 | Henry Schein Inc. | Specific lots were distributed in the US with incorrect packaging and Instructions for Use (IFU) from the U.S. FDA-cleared device. |
| 2024-08-02 | Ultradent Products, Inc. | Due to a manufacturing issue, red particulates present in the expressed composite. |
| 2024-08-02 | Ultradent Products, Inc. | Due to a manufacturing issue, red particulates present in the expressed composite. |
| 2024-08-02 | Ultradent Products, Inc. | Due to a manufacturing issue, red particulates present in the expressed composite. |
| 2020-08-31 | Ultradent Products, Inc. | Due to a potential manufacturing issue (cross contamination), composite is non-homogeneous. |
| 2019-07-09 | Voco GmbH | The metal cannula are potentially too loose and may become loose when applying the filing material. |
| 2019-01-31 | RHONDIUM LIMITED | The product was mislabeled with an incorrect expiration date. |
| 2017-08-03 | Ivoclar Vivadent, Inc. | Complaints were filed claiming the material consistency was too soft and too sticky in comparison to its usual consistency, causing unexpected handling for the user during packing |
| 2017-08-03 | Ivoclar Vivadent, Inc. | Complaints were filed claiming the material consistency was too soft and too sticky in comparison to its usual consistency, causing unexpected handling for the user during packing |
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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.