Browse hierarchy: [Dental (DE)](/submissions/DE) → [Subpart D — Prosthetic Devices](/submissions/DE/subpart-d%E2%80%94prosthetic-devices) → [21 CFR 872.3760](/submissions/DE/subpart-d%E2%80%94prosthetic-devices/872.3760) → EBI — Resin, Denture, Relining, Repairing, Rebasing # EBI · Resin, Denture, Relining, Repairing, Rebasing _Dental · 21 CFR 872.3760 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EBI ## Overview - **Product Code:** EBI - **Device Name:** Resin, Denture, Relining, Repairing, Rebasing - **Regulation:** [21 CFR 872.3760](/submissions/DE/subpart-d%E2%80%94prosthetic-devices/872.3760) - **Device Class:** 2 - **Review Panel:** [Dental](/submissions/DE) - **3rd-party reviewable:** yes ## Identification A denture relining, repairing, or rebasing resin is a device composed of materials such as methylmethacrylate, intended to reline a denture surface that contacts tissue, to repair a fractured denture, or to form a new denture base. This device is not available for over-the-counter (OTC) use. ## Classification Rationale Class II. ## Recent Cleared Devices (20 of 328) Showing 20 most recent of 328 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K253365](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EBI/K253365.md) | LuxCreo Flexible Partial Denture Resin | LuxCreo, Inc. | Nov 25, 2025 | SESE | | [K253681](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EBI/K253681.md) | TERA HARZ Hard Denture (THD-C-500); TERA HARZ Hard Denture (THD-C-1000); TERA HARZ Hard Denture (THD-LP-500); TERA HARZ Hard Denture (THD-LP-1000); TERA HARZ Hard Denture (THD-P-500); TERA HARZ Hard Denture (THD-P-1000); TERA HARZ Hard Denture (THD-CP-500); TERA HARZ Hard Denture (THD-CP-1000) | Graphy, Inc. | Nov 21, 2025 | SESE | | [K253324](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EBI/K253324.md) | UltraPrint-Dental Denture UV | Guangzhou Heygears IMC., Inc. | Nov 20, 2025 | SESE | | [K252430](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EBI/K252430.md) | Freeprint® denture flex | Detax GmbH | Oct 30, 2025 | SESE | | [K252035](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EBI/K252035.md) | DENTURE SOFT EX (Pink set); DENTURE SOFT EX (White set); DENTURE SOFT EX (Pink powder); DENTURE SPFT EX (White powder); DENTURE SOFT EX (Liquid); DENTURE SOFT EX (Trial kit Pink); DENTURE SOFT EX (Trial kit White) | Kamemizu Chemical Industry Co., Ltd. | Sep 17, 2025 | SESE | | [K250302](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EBI/K250302.md) | Flexible Partial Resin | Prismatik Dentalcraft, Inc. | Jun 25, 2025 | SESE | | [K242897](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EBI/K242897.md) | Partial Flex | Clemde SA DE CV | Jun 3, 2025 | SESE | | [K250489](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EBI/K250489.md) | FP3D | Keystone Industries | May 20, 2025 | SESE | | [K250617](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EBI/K250617.md) | Apex Flex | Sprintray, Inc. | Apr 29, 2025 | SESE | | [K243356](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EBI/K243356.md) | Asiga DentaBASE | Asiga Pty, Ltd. | Apr 11, 2025 | SESE | | [K250946](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EBI/K250946.md) | Denture Base Resin DT20 | Hangzhou SHINING3D Dental Technology Co., Ltd. | Mar 31, 2025 | SESE | | [K243103](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EBI/K243103.md) | Denture Base | Riton 3D Technology Co., Ltd. | Dec 23, 2024 | SESE | | [K243336](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EBI/K243336.md) | Lucitone Digital Print Denture™ System | Dentsply Sirona, Inc. | Dec 17, 2024 | SESE | | [K242884](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EBI/K242884.md) | Additively Manufactured Denture Resin | Aidite (Qinhuangdao) Technology Co., Ltd. | Nov 22, 2024 | SESE | | [K241089](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EBI/K241089.md) | KeyPrint KeyDenture Base | Keystone Industries | Oct 24, 2024 | SESE | | [K241493](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EBI/K241493.md) | Glidewell™ 3DP Denture Base Resin | Prismatik Dentalcraft, Inc. | Sep 12, 2024 | SESE | | [K241071](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EBI/K241071.md) | NextDent Jet Denture Base; NextDent Jet Denture Teeth | Vertex-Dental B.V. | Sep 4, 2024 | SESE | | [K240688](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EBI/K240688.md) | RODIN Titan 3D Resin | Belport Company, Inc., Gingi-Pak | Jun 20, 2024 | SESE | | [K233859](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EBI/K233859.md) | BASIS FLOW II | YAMAHACHI DENTAL MFG., Co. | Mar 5, 2024 | SESE | | [K233995](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EBI/K233995.md) | Ivotion Base Print | Ivoclar Vivadent, Inc. | Feb 23, 2024 | SESE | ## Top Applicants - Dentsply Intl. — 16 clearances - GC America, Inc. — 12 clearances - Heraeus Kulzer, Inc. — 11 clearances - Harry J. Bosworth Co. — 8 clearances - Voco GmbH — 8 clearances --- **Source:** [https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EBI](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EBI) **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. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com