Home › Device types › EBF
Material, Tooth Shade, Resin
FDA product code EBF · Class 2 · Dental
20,118
Registered devices
961
Adverse events
71
Recalls
934
510(k) clearances
Devices with this code
Ena HRI ® — MICERIUM SPAHerculite Ultra Flow — Kerr CorporationCERASMART™ — Gc America Inc.FREEPRINT crown A2 1000g — DETAX GmbHVENUS DIAMOND PLT REFILL 1x10x0,25G YO — Kulzer GmbHTecno Med Mineral Dentine — ZIRKONZAHN SRLDurafill VS — Kulzer GmbHBeautifil Flow Plus — SHOFU DENTAL CORPORATIONTooth Shade Resin Material — Liaoning Upcera Co.,Ltd.Tooth Shade Resin Material — Liaoning Upcera Co.,Ltd.edelweiss VENEER 11/21 M — edelweiss dentistry products gmbhTPH Spectra® Universal Composite Restorative Low Viscosity — DENTSPLY INTERNATIONAL INC.SR Nexco — IVOCLAR VIVADENT AKTIENGESELLSCHAFTTooth Shade Resin Material — Liaoning Upcera Co.,Ltd.Renamel® Microfill — COSMEDENT, INC.Charisma ABC — Kulzer GmbH3D Dental - Joy — 3D DENTAL DESIGNS AND DEVELOPMENT, LLCOptiComp — Pac-Dent, Inc.Tooth Shade Resin Material — Liaoning Upcera Co.,Ltd.Tooth Shade Resin Material — Liaoning Upcera Co.,Ltd.Tooth Shade Resin Material — Liaoning Upcera Co.,Ltd.Tooth Shade Resin Material — Liaoning Upcera Co.,Ltd.Tooth Shade Resin Material — Liaoning Upcera Co.,Ltd.Tooth Shade Resin Material — Liaoning Upcera Co.,Ltd.
Recent 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 |
| 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 |
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