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 |
|---|---|---|---|
| K261485 | ivoclar vivadent | Tetric plus Fill;Tetric plus Flow | July 1, 2026 |
| K262228 | ultradent products | Transcend Bulk Fill Flowable Composite | July 1, 2026 |
| K261246 | gc america | SRGC-06 | June 18, 2026 |
| K261093 | diadent group international | DIAFIL | June 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 | April 27, 2026 |
| K261356 | hangzhou shining3d dental technology co | Dura-Crown | April 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) | April 23, 2026 |
| K260661 | sprintray | Midas Restore | April 15, 2026 |
| K253036 | aidite (qinhuangdao) technology co | Light-curing Coloring Materials (ALCM) | April 6, 2026 |
| K260783 | kulzer | Venus Diamond; Venus Diamond Flow; Venus Pearl; Venus Bulk Flow One | March 11, 2026 |
| K254245 | new stetic | ZAFIRA® | March 3, 2026 |
| K260170 | hangzhou shining3d dental technology co | LumiCera | January 21, 2026 |
| K252465 | mediclus co | Any-Core | December 5, 2025 |
| K253513 | premier dental products | MultiMatch Flow Chameleon AntiMicrobial Composite | November 7, 2025 |
| K253236 | graphenano dental s.l | G-BLOCK | September 29, 2025 |
| K253053 | hangzhou shining3d dental technology co | Dura-Crown (CB21-A1/CB21-A2/CB21-A3/CB21-B1) | September 23, 2025 |
| K251946 | gc america | G aenial Universal Injectable II | August 29, 2025 |
| K251283 | mediclus co | Once-Fil Flow | June 6, 2025 |