Product code EBF
- Device name
- Material, Tooth Shade, Resin
- Medical specialty
- Dental
- Device class
- 2
- Regulation number
- 872.3690
- Review panel
- DE
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K261071 | DIAFIL Bulk FLOW (Economic Package);DIAFIL Bulk FLOW (Refill Package);DIAFIL Bulk FLOW (0.5g) | DiaDent Group International | 2026-05-19 |
| K260805 | Dual Core | Vericom Co., Ltd. | 2026-05-11 |
| K261357 | Grandio disc multicolor | Voco GmbH | 2026-04-27 |
| K261356 | Dura-Crown | Hangzhou SHINING3D Dental Technology Co., Ltd. | 2026-04-27 |
| K260152 | Smart Print Bio Vitality (A2, A3, BL1, B1, A2-HT, A3-HT, BL1-HT, B1-HT) | Mmtech Projetos Tecnologicos Importacao E Exportacao Ltda. | 2026-04-23 |
| K260661 | Midas Restore | Sprintray, Inc. | 2026-04-15 |
| K253036 | Light-curing Coloring Materials (ALCM) | Aidite (Qinhuangdao) Technology Co., Ltd. | 2026-04-06 |
| K260783 | Venus Diamond; Venus Diamond Flow; Venus Pearl; Venus Bulk Flow One | Kulzer, LLC | 2026-03-11 |
| K254245 | ZAFIRA® | New Stetic, SA | 2026-03-03 |
| K260170 | LumiCera | Hangzhou SHINING3D Dental Technology Co., Ltd. | 2026-01-21 |
| K252465 | Any-Core | Mediclus Co., Ltd. | 2025-12-05 |
| K253513 | MultiMatch Flow Chameleon AntiMicrobial Composite | Premier Dental Products Company | 2025-11-07 |
| K253236 | G-BLOCK | Graphenano Dental S.L. | 2025-09-29 |
| K253053 | Dura-Crown (CB21-A1/CB21-A2/CB21-A3/CB21-B1) | Hangzhou SHINING3D Dental Technology Co., Ltd. | 2025-09-23 |
| K251946 | G aenial Universal Injectable II | GC America, Inc. | 2025-08-29 |
| K251283 | Once-Fil Flow | Mediclus Co., Ltd. | 2025-06-06 |
| K250317 | EsFlow PLUS | Spident Co., Ltd. | 2025-05-30 |
| K251578 | BEAUTIFIL II | Shofu Dental Corporation | 2025-05-27 |
| K250778 | Sil-Flow | Dsi Dental Solutions, Ltd. | 2025-05-23 |
| K251239 | GrandioSO Unlimited | Voco GmbH | 2025-05-21 |
| K250763 | Reon | C.E.I.B.Med | 2025-05-12 |
| K250497 | Additive Manufacturing (Light Curing) Crown Bridge Resin | Aidite (Qinhuangdao) Technology Co., Ltd. | 2025-04-30 |
| K250823 | Any-Com Flow | Mediclus Co., Ltd. | 2025-04-14 |
| K250267 | Visalys® Bulk Fill 1 x 4 g Syringe (15060); Visalys® Bulk Fill 15 x 0.25 g Caps (15062); Visalys® Bulk Flow 1 x 2 g Syringe (15064); Visalys® Bulk Flow 15 x 0.25 g Caps (15066); Visalys® Bulk Flow Intro pack (15067); Visalys® Bulk Intro ... | Kettenbach GmbH & Co. KG | 2025-03-14 |
| K242713 | Any-Com Bulk | Mediclus Co., Ltd. | 2025-02-07 |
| K242572 | TopCEM-Try in Veneer Try-in Gel | Rizhao Huge Biomaterials Company, Ltd. | 2024-12-20 |
| K243720 | 3Delta UNlimited | Deltamed GmbH | 2024-12-18 |
| K242816 | Quantium | Bisco, Inc. | 2024-12-17 |
| K233273 | C&B Ceramic; C&B Permanent; C&B Interim | Prevest Denpro Limited | 2024-11-27 |
| K232994 | Vittra APS Unique Flow | Dentscare Ltda | 2024-10-18 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 08809254453943 | Dual Core | VERICOM CO., LTD. | 2026-05-27 |
| 08809254453875 | Dual Core | VERICOM CO., LTD. | 2026-05-27 |
| EMICEHR6T1 | Ena HRI ® | MICERIUM SPA | 2021-12-09 |
| EMICEHFUD61 | Ena HFO ® | MICERIUM SPA | 2021-12-01 |
| ESDG2320491 | Capo Natural Incisal medium, 4 g | Schütz Dental GmbH | 2016-11-08 |
| ESDG2320521 | Capo Natural Bleach 1, 4 g | Schütz Dental GmbH | 2016-11-07 |
| ESDG2320511 | Capo Natural Incisal white, 4 g | Schütz Dental GmbH | 2016-11-07 |
| ESDG2320501 | Capo Natural Incisal clear, 4 g | Schütz Dental GmbH | 2016-11-07 |
| ESDG2320531 | Capo Natural Bleach 2, 4 g | Schütz Dental GmbH | 2016-11-07 |
| ESDG2320481 | Capo Natural C 3, 4 g | Schütz Dental GmbH | 2016-11-07 |
| ESDG2320471 | Capo Natural C 2, 4 g | Schütz Dental GmbH | 2016-11-07 |
| ESDG2320461 | Capo Natural B 3, 4 g | Schütz Dental GmbH | 2016-11-07 |
| ESDG2320451 | Capo Natural B 2, 4 g | Schütz Dental GmbH | 2016-11-07 |
| ESDG2320441 | Capo Natural A 4, 4 g | Schütz Dental GmbH | 2016-11-07 |
| ESDG2320431 | Capo Natural A 3.5, 4 g | Schütz Dental GmbH | 2016-11-07 |
| ESDG2320421 | Capo Natural A 3, 4 g | Schütz Dental GmbH | 2016-11-07 |
| ESDG2320411 | Capo Natural A 2, 4 g | Schütz Dental GmbH | 2016-11-07 |
| ESDG2320401 | Capo Natural A 1, 4 g | Schütz Dental GmbH | 2016-11-07 |
| ESDG2320361 | Capo Hybrid C 3, 5 g | Schütz Dental GmbH | 2016-11-07 |
| ESDG2320351 | Capo Hybrid A 3.5, 5 g | Schütz Dental GmbH | 2016-11-07 |
| ESDG2320301 | Capo Hybrid Occlusal white, 5 g | Schütz Dental GmbH | 2016-11-07 |
| ESDG2320291 | Capo Hybrid Occlusal clear, 5 g | Schütz Dental GmbH | 2016-11-07 |
| ESDG2320281 | Capo Hybrid Incisal Medium, 5 g | Schütz Dental GmbH | 2016-11-07 |
| ESDG2320261 | Capo Hybrid C 2, 5 g | Schütz Dental GmbH | 2016-11-07 |
| ESDG2320251 | Capo Hybrid B 3, 5 g | Schütz Dental GmbH | 2016-11-07 |
| ESDG2320241 | Capo Hybrid B 2, 5 g | Schütz Dental GmbH | 2016-11-07 |
| ESDG2320231 | Capo Hybrid A 4, 5 g | Schütz Dental GmbH | 2016-11-07 |
| ESDG2320221 | Capo Hybrid A 3, 5 g | Schütz Dental GmbH | 2016-11-07 |
| ESDG2320211 | Capo Hybrid A 2, 5 g | Schütz Dental GmbH | 2016-11-07 |
| ESDG2320201 | Capo Hybrid A 1, 5 g | Schütz Dental GmbH | 2016-11-07 |