EBF — Material, Tooth Shade, Resin Class II
FDA product code EBF covers "Material, Tooth Shade, Resin", a Class II medical device regulated under 21 CFR 872.3690. Submissions are reviewed by the Dental panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- EBF
- Device Class
- Class II
- Regulation Number
- 872.3690
- Submission Type
- Review Panel
- DE
- Medical Specialty
- Dental
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K262202 | Gc America | Cerasmart Forte | Sep 10, 2026 |
| K261695 | Guilin Kevin Peter Technology Co | Flowable Restorative Material (KP-Flow LF, KP-Flow MF, KP-Flow HF) | Aug 31, 2026 |
| K261485 | Ivoclar Vivadent | Tetric plus Fill;Tetric plus Flow | Jul 1, 2026 |
| K262228 | Ultradent Products | Transcend Bulk Fill Flowable Composite | Jul 1, 2026 |
| K261246 | Gc America | SRGC-06 | Jun 18, 2026 |
| K261093 | Diadent Group International | DIAFIL | Jun 2, 2026 |
| K261071 | Diadent Group International | DIAFIL Bulk FLOW (Economic Package);DIAFIL Bulk FLOW (Refill Package);DIAFIL Bul | May 19, 2026 |
| K260805 | Vericom Co | Dual Core | May 11, 2026 |
| K261357 | Voco | Grandio disc multicolor | Apr 27, 2026 |
| K261356 | Hangzhou Shining3D Dental Technology Co | Dura-Crown | Apr 27, 2026 |
| K260152 | Mmtech Projetos Tecnologicos Importacao E Exportacao Ltda | Smart Print Bio Vitality (A2, A3, BL1, B1, A2-HT, A3-HT, BL1-HT, B1-HT) | Apr 23, 2026 |
| K260661 | Sprintray | Midas Restore | Apr 15, 2026 |
| K253036 | Aidite (Qinhuangdao) Technology Co | Light-curing Coloring Materials (ALCM) | Apr 6, 2026 |
| K260783 | Kulzer | Venus Diamond; Venus Diamond Flow; Venus Pearl; Venus Bulk Flow One | Mar 11, 2026 |
| K254245 | New Stetic | ZAFIRA® | Mar 3, 2026 |
| K260170 | Hangzhou Shining3D Dental Technology Co | LumiCera | Jan 21, 2026 |
| K252465 | Mediclus Co | Any-Core | Dec 5, 2025 |
| K253513 | Premier Dental Products | MultiMatch Flow Chameleon AntiMicrobial Composite | Nov 7, 2025 |
| K253236 | Graphenano Dental S.L | G-BLOCK | Sep 29, 2025 |
| K253053 | Hangzhou Shining3D Dental Technology Co | Dura-Crown (CB21-A1/CB21-A2/CB21-A3/CB21-B1) | Sep 23, 2025 |