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 |
|---|---|---|---|
| K262982 | Core·it Dual | Spident Co., Ltd. | 2026-09-21 |
| K262202 | Cerasmart Forte | GC America, Inc. | 2026-09-10 |
| K261695 | Flowable Restorative Material (KP-Flow LF, KP-Flow MF, KP-Flow HF) | Guilin Kevin Peter Technology Co., Ltd. | 2026-08-31 |
| K261485 | Tetric plus Fill;Tetric plus Flow | Ivoclar Vivadent, Inc. | 2026-07-01 |
| K262228 | Transcend Bulk Fill Flowable Composite | Ultradent Products, Inc. | 2026-07-01 |
| K261246 | SRGC-06 | GC America, Inc. | 2026-06-18 |
| 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 |
| K261356 | Dura-Crown | Hangzhou SHINING3D Dental Technology Co., Ltd. | 2026-04-27 |
| K261357 | Grandio disc multicolor | Voco GmbH | 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 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00810111543644 | Quantium | BISCO INC. | 2026-10-12 |
| 00810222900206 | SprintRay Crown HT A1 Single-Unit Capsule - Japan | Sprintray, Inc. | 2026-10-09 |
| 00810222900312 | SprintRay Crown HT A2 Single-Unit Capsule 3-Pack - JP | Sprintray, Inc. | 2026-10-09 |
| 00810222900305 | SprintRay Crown HT A1 Single-Unit Capsule 3-Pack - JP | Sprintray, Inc. | 2026-10-09 |
| 00810222900299 | SprintRay Crown HT Unpigmented Single-unit Capsule 3-Pack - JP | Sprintray, Inc. | 2026-10-09 |
| 00810222900282 | SprintRay Crown HT Unpigmented Single-Unit Capsule - JP | Sprintray, Inc. | 2026-10-09 |
| 00810222900275 | SprintRay Crown HT A3 Single-unit Capsule 3-Pack - JP | Sprintray, Inc. | 2026-10-09 |
| 00810222900268 | SprintRay Crown HT A3 Single-Unit Capsule - JP | Sprintray, Inc. | 2026-10-09 |
| 00810222900251 | SprintRay Crown HT Bleach Single-Unit Capsule 3-Pack - JP | Sprintray, Inc. | 2026-10-09 |
| 00810222900244 | SprintRay Crown HT B1 Single-Unit Capsule 3-Pack - JP | Sprintray, Inc. | 2026-10-09 |
| 00810222900237 | SprintRay Crown HT B1 Single-Unit Capsule - JP | Sprintray, Inc. | 2026-10-09 |
| 00810222900220 | SprintRay Crown HT Bleach Single-Unit Capsule - JP | Sprintray, Inc. | 2026-10-09 |
| 00810222900213 | SprintRay Crown HT A2 Single-Unit Capsule - JP | Sprintray, Inc. | 2026-10-09 |
| 00197998226724 | Solventum™ Protemp™ | Solventum Germany GmbH | 2026-10-08 |
| 08806383541169 | DIAFIL | DiaDent Group International | 2026-10-07 |
| 08806383541152 | DIAFIL | DiaDent Group International | 2026-10-07 |
| 08806383541145 | DIAFIL | DiaDent Group International | 2026-10-07 |
| 08806383541138 | DIAFIL | DiaDent Group International | 2026-10-07 |
| 08806383541121 | DIAFIL | DiaDent Group International | 2026-10-07 |
| 08806383541114 | DIAFIL | DiaDent Group International | 2026-10-07 |
| 08806383541107 | DIAFIL | DiaDent Group International | 2026-10-07 |
| 08806383541091 | DIAFIL | DiaDent Group International | 2026-10-07 |
| 08806383541060 | DIAFIL | DiaDent Group International | 2026-10-07 |
| 08806383541053 | DIAFIL | DiaDent Group International | 2026-10-07 |
| 08806383541046 | DIAFIL | DiaDent Group International | 2026-10-07 |
| 08806383541039 | DIAFIL | DiaDent Group International | 2026-10-07 |
| 08806383541022 | DIAFIL | DiaDent Group International | 2026-10-07 |
| 08806383541015 | DIAFIL | DiaDent Group International | 2026-10-07 |
| 08806383541008 | DIAFIL | DiaDent Group International | 2026-10-07 |
| 08806383540995 | DIAFIL | DiaDent Group International | 2026-10-07 |