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/submissions/DE/subpart-d%E2%80%94prosthetic-devices/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 924) Showing 20 most recent of 924 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K253036](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EBF/K253036.md) | Light-curing Coloring Materials (ALCM) | Aidite (Qinhuangdao) Technology Co., Ltd. | Apr 6, 2026 | SESE | | [K260783](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EBF/K260783.md) | Venus Diamond; Venus Diamond Flow; Venus Pearl; Venus Bulk Flow One | Kulzer, LLC | Mar 11, 2026 | SESE | | [K254245](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EBF/K254245.md) | ZAFIRA® | New Stetic, SA | Mar 3, 2026 | SESE | | [K260170](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EBF/K260170.md) | LumiCera | Hangzhou SHINING3D Dental Technology Co., Ltd. | Jan 21, 2026 | SESE | | [K252465](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EBF/K252465.md) | Any-Core | Mediclus Co., Ltd. | Dec 5, 2025 | SESE | | [K253513](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EBF/K253513.md) | MultiMatch Flow Chameleon AntiMicrobial Composite | Premier Dental Products Company | Nov 7, 2025 | SESE | | [K253236](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EBF/K253236.md) | G-BLOCK | Graphenano Dental S.L. | Sep 29, 2025 | SESE | | [K253053](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EBF/K253053.md) | Dura-Crown (CB21-A1/CB21-A2/CB21-A3/CB21-B1) | Hangzhou SHINING3D Dental Technology Co., Ltd. | Sep 23, 2025 | SESE | | [K251946](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EBF/K251946.md) | G aenial Universal Injectable II | GC America, Inc. | Aug 29, 2025 | SESE | | [K251283](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EBF/K251283.md) | Once-Fil Flow | Mediclus Co., Ltd. | Jun 6, 2025 | SESE | | [K250317](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EBF/K250317.md) | EsFlow PLUS | Spident Co., Ltd. | May 30, 2025 | SESE | | [K251578](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EBF/K251578.md) | BEAUTIFIL II | Shofu Dental Corporation | May 27, 2025 | SESE | | [K250778](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EBF/K250778.md) | Sil-Flow | Dsi Dental Solutions, Ltd. | May 23, 2025 | SESE | | [K251239](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EBF/K251239.md) | GrandioSO Unlimited | Voco GmbH | May 21, 2025 | SESE | | [K250763](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EBF/K250763.md) | Reon | C.E.I.B.Med | May 12, 2025 | SESE | | [K250497](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EBF/K250497.md) | Additive Manufacturing (Light Curing) Crown Bridge Resin | Aidite (Qinhuangdao) Technology Co., Ltd. | Apr 30, 2025 | SESE | | [K250823](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EBF/K250823.md) | Any-Com Flow | Mediclus Co., Ltd. | Apr 14, 2025 | SESE | | [K250267](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EBF/K250267.md) | 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](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EBF/K242713.md) | Any-Com Bulk | Mediclus Co., Ltd. | Feb 7, 2025 | SESE | | [K242572](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EBF/K242572.md) | 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 - Dentsply Intl. — 28 clearances - Ivoclar North America, Inc. — 28 clearances --- **Source:** [https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EBF](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EBF) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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