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 |
|---|---|---|---|
| K261093 | DIAFIL | DiaDent Group International | 2026-06-02 |
| 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 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 06975338702947 | SHINING 3D® | Hangzhou SHINING3D Dental Technology Co., Ltd. | 2026-06-02 |
| 06975338703371 | SHINING 3D® | Hangzhou SHINING3D Dental Technology Co., Ltd. | 2026-06-02 |
| 06975338703364 | SHINING 3D® | Hangzhou SHINING3D Dental Technology Co., Ltd. | 2026-06-02 |
| 06975338703357 | SHINING 3D® | Hangzhou SHINING3D Dental Technology Co., Ltd. | 2026-06-02 |
| 06975338703104 | SHINING 3D® | Hangzhou SHINING3D Dental Technology Co., Ltd. | 2026-06-02 |
| 06975338703098 | SHINING 3D® | Hangzhou SHINING3D Dental Technology Co., Ltd. | 2026-06-02 |
| 06975338703081 | SHINING 3D® | Hangzhou SHINING3D Dental Technology Co., Ltd. | 2026-06-02 |
| 06975338703074 | SHINING 3D® | Hangzhou SHINING3D Dental Technology Co., Ltd. | 2026-06-02 |
| 06975338703029 | SHINING 3D® | Hangzhou SHINING3D Dental Technology Co., Ltd. | 2026-06-02 |
| 06975338703012 | SHINING 3D® | Hangzhou SHINING3D Dental Technology Co., Ltd. | 2026-06-02 |
| 06975338703005 | SHINING 3D® | Hangzhou SHINING3D Dental Technology Co., Ltd. | 2026-06-02 |
| 06975338702992 | SHINING 3D® | Hangzhou SHINING3D Dental Technology Co., Ltd. | 2026-06-02 |
| 06975338702930 | SHINING 3D® | Hangzhou SHINING3D Dental Technology Co., Ltd. | 2026-06-02 |
| 06975338702923 | SHINING 3D® | Hangzhou SHINING3D Dental Technology Co., Ltd. | 2026-06-02 |
| 06975338702916 | SHINING 3D® | Hangzhou SHINING3D Dental Technology Co., Ltd. | 2026-06-02 |
| 00348783001051 | MultiMatch | PREMIER DENTAL PRODUCTS COMPANY | 2026-06-02 |
| 00348783001044 | MultiMatch | PREMIER DENTAL PRODUCTS COMPANY | 2026-06-02 |
| 00348783000993 | MultiMatch | PREMIER DENTAL PRODUCTS COMPANY | 2026-06-02 |
| 00348783000979 | MultiMatch | PREMIER DENTAL PRODUCTS COMPANY | 2026-06-02 |
| 00348783000955 | MultiMatch | PREMIER DENTAL PRODUCTS COMPANY | 2026-06-02 |
| 00348783000931 | MultiMatch | PREMIER DENTAL PRODUCTS COMPANY | 2026-06-02 |
| 06975338703388 | SHINING 3D® | Hangzhou SHINING3D Dental Technology Co., Ltd. | 2026-06-02 |
| 00348783000917 | MultiMatch | PREMIER DENTAL PRODUCTS COMPANY | 2026-06-01 |
| D14307560147449650 | Smart Dent ® | MMTECH PROJETOS TECNOLOGICOS IMPORTACAO E EXPORTACAO LTDA. | 2026-05-29 |
| D14307560147448280 | Smart Dent ® | MMTECH PROJETOS TECNOLOGICOS IMPORTACAO E EXPORTACAO LTDA. | 2026-05-29 |
| D14307560147448350 | Smart Dent ® | MMTECH PROJETOS TECNOLOGICOS IMPORTACAO E EXPORTACAO LTDA. | 2026-05-29 |
| D14307560147448110 | Smart Dent ® | MMTECH PROJETOS TECNOLOGICOS IMPORTACAO E EXPORTACAO LTDA. | 2026-05-29 |
| D14307560147448040 | Smart Dent ® | MMTECH PROJETOS TECNOLOGICOS IMPORTACAO E EXPORTACAO LTDA. | 2026-05-29 |
| 08809254452618 | Dual Core | VERICOM CO., LTD. | 2026-05-27 |
| 08809254452571 | Dual Core | VERICOM CO., LTD. | 2026-05-27 |