Browse hierarchy: [Dental (DE)](/submissions/DE) → [Subpart D — Prosthetic Devices](/submissions/DE/subpart-d%E2%80%94prosthetic-devices) → [21 CFR 872.3770](/submissions/DE/subpart-d%E2%80%94prosthetic-devices/872.3770) → EBG — Crown And Bridge, Temporary, Resin # EBG · Crown And Bridge, Temporary, Resin _Dental · 21 CFR 872.3770 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EBG ## Overview - **Product Code:** EBG - **Device Name:** Crown And Bridge, Temporary, Resin - **Regulation:** [21 CFR 872.3770](/submissions/DE/subpart-d%E2%80%94prosthetic-devices/872.3770) - **Device Class:** 2 - **Review Panel:** [Dental](/submissions/DE) - **3rd-party reviewable:** yes ## Identification A temporary crown and bridge resin is a device composed of a material, such as polymethylmethacrylate, intended to make a temporary prosthesis, such as a crown or bridge, for use until a permanent restoration is fabricated. ## Classification Rationale Class II. ## Recent Cleared Devices (20 of 189) Showing 20 most recent of 189 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K261261](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EBG/K261261.md) | Dura-Arch | Hangzhou SHINING3D Dental Technology Co., Ltd. | Apr 17, 2026 | SESE | | [K253380](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EBG/K253380.md) | “FLNT Base” and “FLNT Temp” | Liaoning Upcera Co., Ltd. | Mar 2, 2026 | SESE | | [K251271](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EBG/K251271.md) | TempFIT Temporary Crown and Bridge Resin | Rizhao Huge Biomaterials Company, Ltd. | Jun 23, 2025 | SESE | | [K243370](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EBG/K243370.md) | DentaTOOTH | Asiga Pty, Ltd. | May 5, 2025 | SESE | | [K243621](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EBG/K243621.md) | Evoblock, Perléon | Evoden Indústria Comércio Importação E Exportação | Apr 22, 2025 | SESE | | [K243951](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EBG/K243951.md) | TEMP MASTER, PMMA-based dental resin | Taiwan Dental Materials Co., Ltd. | Feb 21, 2025 | SESE | | [K242559](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EBG/K242559.md) | Digital Temp | Sprintray, Inc. | Nov 26, 2024 | SESE | | [K231859](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EBG/K231859.md) | PrimmaArt | Dentscare Ltda | Nov 26, 2024 | SESE | | [K240538](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EBG/K240538.md) | Premium Teeth Resin | Formlabs Ohio, Inc. | Jul 19, 2024 | SESE | | [K241226](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EBG/K241226.md) | Fixtemp® C&B 4:1 | Dreve Denatmid GmbH | May 31, 2024 | SESE | | [K233868](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EBG/K233868.md) | dima Print Teeth & Temp | Kulzer, LLC | May 23, 2024 | SESE | | [K223706](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EBG/K223706.md) | PMMA BLOCK | Huliang(Shanghai) Bio-Tech Co., Ltd. | May 12, 2023 | SESE | | [K223477](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EBG/K223477.md) | PMMA Blocks for Dental Use | Aidite (Qinhuangdao) Technology Co., Ltd. | Feb 16, 2023 | SESE | | [K202965](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EBG/K202965.md) | CURA-Temp | Mgnewton , Ltd. | Dec 21, 2022 | SESE | | [K214071](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EBG/K214071.md) | Hexa-Temp | Spident Co., Ltd. | Mar 10, 2022 | SESE | | [K213643](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EBG/K213643.md) | UltraPrint-Dental Temp C&B UV | Guangzhou Heygears IMC., Inc. | Jan 14, 2022 | SESE | | [K210817](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EBG/K210817.md) | C&B 5.0 Hybrid | Arum Dentistry Co., Ltd. | Dec 8, 2021 | SESE | | [K211101](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EBG/K211101.md) | E-Temp | Envisiontec GmbH | Jun 14, 2021 | SESE | | [K201563](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EBG/K201563.md) | PuRE PMMA Disc | Quest Dental USA Corp. | Apr 9, 2021 | SESE | | [K190217](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EBG/K190217.md) | Aidite PMMA | Aidite (Qinhuangdao) Technology Co., Ltd. | Dec 17, 2020 | SESE | ## Top Applicants - Sybron Dental Specialties, Inc. — 6 clearances - Ivoclar Vivadent, Inc. — 6 clearances - GC America, Inc. — 6 clearances - Voco GmbH — 5 clearances - Dmg USA, Inc. — 5 clearances --- **Source:** [https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EBG](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EBG) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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