Home › Device types › EBF
Material, Tooth Shade, Resin
FDA product code EBF · Class 2 · Dental
20,574
Registered devices
962
Adverse events
71
Recalls
937
510(k) clearances
Devices with this code
NovaPro — NANOVA BIO MATERIALS INCHerculite Ultra — Kerr CorporationPoint 4 — Kerr CorporationRodin — Pac-Dent, Inc.Tooth Shade Resin Material — Liaoning Upcera Co.,Ltd.Tetric EvoCeram — IVOCLAR VIVADENT AKTIENGESELLSCHAFTVenus Diamond — Kulzer GmbHG-aenial™ — Gc America Inc.Acorn Single Dose Caps. Sh. A3 — DENT ZAR, INC.Renamel® Microfill — COSMEDENT, INC.Grandio blocs — VOCO GmbHVeneer Try-in Gel — Rizhao HuGe Biomaterials Company, Ltd.MAZIC Duro — VERICOM CO., LTD.CLEARFIL MAJESTY™ IC Bulk — KURARAY NORITAKE DENTAL 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.Vittra APS — Dentscare LtdaMAZIC Duro — VERICOM CO., LTD.AELITE LS Posterior A2 Sample — BISCO INC.CERASMART® — Gc America Inc.Choice 2 Try-In Paste — BISCO INC.G-CAM — GRAPHENANO DENTAL SL.
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 |
Query this across every FDA database — by API.
Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.
Get your free API keyRead the docsSourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.