Browse hierarchy: [Dental (DE)](/submissions/DE) → [Subpart D — Prosthetic Devices](/submissions/DE/subpart-d%E2%80%94prosthetic-devices) → [21 CFR 872.3690](/submissions/DE/subpart-d%E2%80%94prosthetic-devices/872.3690) → EBF — Material, Tooth Shade, Resin

# EBF · Material, Tooth Shade, Resin

_Dental · 21 CFR 872.3690 · Class 2_

**Canonical URL:** https://fda.innolitics.com/productcode/EBF

## Overview

- **Product Code:** EBF
- **Device Name:** Material, Tooth Shade, Resin
- **Regulation:** [21 CFR 872.3690](/submissions/DE/subpart-d%E2%80%94prosthetic-devices/872.3690)
- **Device Class:** 2
- **Review Panel:** [Dental](/submissions/DE)
- **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 931)

Showing 20 most recent of 931 cleared devices.

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K261093](/device/K261093.md) | DIAFIL | DiaDent Group International | Jun 2, 2026 | SESE |
| [K261071](/device/K261071.md) | DIAFIL Bulk FLOW (Economic Package);DIAFIL Bulk FLOW (Refill Package);DIAFIL Bulk FLOW (0.5g) | DiaDent Group International | May 19, 2026 | SESE |
| [K260805](/device/K260805.md) | Dual Core | Vericom Co., Ltd. | May 11, 2026 | SESE |
| [K261357](/device/K261357.md) | Grandio disc multicolor | Voco GmbH | Apr 27, 2026 | SESE |
| [K261356](/device/K261356.md) | Dura-Crown | Hangzhou SHINING3D Dental Technology Co., Ltd. | Apr 27, 2026 | SESE |
| [K260152](/device/K260152.md) | Smart Print Bio Vitality (A2, A3, BL1, B1, A2-HT, A3-HT, BL1-HT, B1-HT) | Mmtech Projetos Tecnologicos Importacao E Exportacao Ltda. | Apr 23, 2026 | SESE |
| [K260661](/device/K260661.md) | Midas Restore | Sprintray, Inc. | Apr 15, 2026 | SESE |
| [K253036](/device/K253036.md) | Light-curing Coloring Materials (ALCM) | Aidite (Qinhuangdao) Technology Co., Ltd. | Apr 6, 2026 | SESE |
| [K260783](/device/K260783.md) | Venus Diamond; Venus Diamond Flow; Venus Pearl; Venus Bulk Flow One | Kulzer, LLC | Mar 11, 2026 | SESE |
| [K254245](/device/K254245.md) | ZAFIRA® | New Stetic, SA | Mar 3, 2026 | SESE |
| [K260170](/device/K260170.md) | LumiCera | Hangzhou SHINING3D Dental Technology Co., Ltd. | Jan 21, 2026 | SESE |
| [K252465](/device/K252465.md) | Any-Core | Mediclus Co., Ltd. | Dec 5, 2025 | SESE |
| [K253513](/device/K253513.md) | MultiMatch Flow Chameleon AntiMicrobial Composite | Premier Dental Products Company | Nov 7, 2025 | SESE |
| [K253236](/device/K253236.md) | G-BLOCK | Graphenano Dental S.L. | Sep 29, 2025 | SESE |
| [K253053](/device/K253053.md) | Dura-Crown (CB21-A1/CB21-A2/CB21-A3/CB21-B1) | Hangzhou SHINING3D Dental Technology Co., Ltd. | Sep 23, 2025 | SESE |
| [K251946](/device/K251946.md) | G aenial Universal Injectable II | GC America, Inc. | Aug 29, 2025 | SESE |
| [K251283](/device/K251283.md) | Once-Fil Flow | Mediclus Co., Ltd. | Jun 6, 2025 | SESE |
| [K250317](/device/K250317.md) | EsFlow PLUS | Spident Co., Ltd. | May 30, 2025 | SESE |
| [K251578](/device/K251578.md) | BEAUTIFIL II | Shofu Dental Corporation | May 27, 2025 | SESE |
| [K250778](/device/K250778.md) | Sil-Flow | Dsi Dental Solutions, Ltd. | May 23, 2025 | SESE |

## Top Applicants

- Voco GmbH — 45 clearances
- Bisco, Inc. — 30 clearances
- Scientific Pharmaceuticals, Inc. — 29 clearances
- Dentsply Intl. — 28 clearances
- Ivoclar North America, Inc. — 28 clearances

---

**Source:** [https://fda.innolitics.com/productcode/EBF](https://fda.innolitics.com/productcode/EBF)

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