EBF · Material, Tooth Shade, Resin
Dental · 21 CFR 872.3690 · Class 2
Overview
| Product Code | EBF |
|---|---|
| Device Name | Material, Tooth Shade, Resin |
| Regulation | 21 CFR 872.3690 |
| Device Class | Class 2 |
| Review Panel | Dental |
| 3rd-Party Reviewable | Yes |
Identification
Tooth shade resin material is a device composed of materials such as bisphenol-A glycidyl methacrylate (Bis-GMA) intended to restore carious lesions or structural defects in teeth.
Classification Rationale
Class II.
Recent Cleared Devices (20 of 924)
Showing 20 most recent of 924 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K253036 | Light-curing Coloring Materials (ALCM) | Aidite (Qinhuangdao) Technology Co., Ltd. | Apr 6, 2026 | SESE |
| K260783 | Venus Diamond; Venus Diamond Flow; Venus Pearl; Venus Bulk Flow One | Kulzer, LLC | Mar 11, 2026 | SESE |
| K254245 | ZAFIRA® | New Stetic, SA | Mar 3, 2026 | SESE |
| K260170 | LumiCera | Hangzhou SHINING3D Dental Technology Co., Ltd. | Jan 21, 2026 | SESE |
| K252465 | Any-Core | Mediclus Co., Ltd. | Dec 5, 2025 | SESE |
| K253513 | MultiMatch Flow Chameleon AntiMicrobial Composite | Premier Dental Products Company | Nov 7, 2025 | SESE |
| K253236 | G-BLOCK | Graphenano Dental S.L. | Sep 29, 2025 | SESE |
| K253053 | Dura-Crown (CB21-A1/CB21-A2/CB21-A3/CB21-B1) | Hangzhou SHINING3D Dental Technology Co., Ltd. | Sep 23, 2025 | SESE |
| K251946 | G aenial Universal Injectable II | GC America, Inc. | Aug 29, 2025 | SESE |
| K251283 | Once-Fil Flow | Mediclus Co., Ltd. | Jun 6, 2025 | SESE |
| K250317 | EsFlow PLUS | Spident Co., Ltd. | May 30, 2025 | SESE |
| K251578 | BEAUTIFIL II | Shofu Dental Corporation | May 27, 2025 | SESE |
| K250778 | Sil-Flow | Dsi Dental Solutions, Ltd. | May 23, 2025 | SESE |
| K251239 | GrandioSO Unlimited | Voco GmbH | May 21, 2025 | SESE |
| K250763 | Reon | C.E.I.B.Med | May 12, 2025 | SESE |
| K250497 | Additive Manufacturing (Light Curing) Crown Bridge Resin | Aidite (Qinhuangdao) Technology Co., Ltd. | Apr 30, 2025 | SESE |
| K250823 | Any-Com Flow | Mediclus Co., Ltd. | Apr 14, 2025 | SESE |
| 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 pack (15068) | Kettenbach GmbH & Co. KG | Mar 14, 2025 | SESE |
| K242713 | Any-Com Bulk | Mediclus Co., Ltd. | Feb 7, 2025 | SESE |
| K242572 | TopCEM-Try in Veneer Try-in Gel | Rizhao Huge Biomaterials Company, Ltd. | Dec 20, 2024 | SESE |
Top Applicants
- Voco GmbH — 44 clearances
- Bisco, Inc. — 30 clearances
- Scientific Pharmaceuticals, Inc. — 29 clearances
- Ivoclar North America, Inc. — 28 clearances
- Dentsply Intl. — 28 clearances
