EBF — Material, Tooth Shade, Resin Class II
FDA Device Classification
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 |
|---|
| 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 |
| K250317 | spident co | EsFlow PLUS | May 30, 2025 |
| K251578 | shofu dental corporation | BEAUTIFIL II | May 27, 2025 |
| K250778 | dsi dental solutions | Sil-Flow | May 23, 2025 |
| K251239 | voco | GrandioSO Unlimited | May 21, 2025 |
| K250763 | c.e.i.b.med | Reon | May 12, 2025 |
| K250497 | aidite (qinhuangdao) technology co | Additive Manufacturing (Light Curing) Crown Bridge Resin | April 30, 2025 |
| K250823 | mediclus co | Any-Com Flow | April 14, 2025 |
| K250267 | kettenbach gmbh and co. kg | Visalys® Bulk Fill 1 x 4 g Syringe (15060); Visalys® Bulk Fill 15 x 0.25 g Caps | March 14, 2025 |
| K242713 | mediclus co | Any-Com Bulk | February 7, 2025 |
| K242572 | rizhao huge biomaterials company | TopCEM-Try in Veneer Try-in Gel | December 20, 2024 |
| K243720 | deltamed | 3Delta UNlimited | December 18, 2024 |