EBI · Resin, Denture, Relining, Repairing, Rebasing
Dental · 21 CFR 872.3760 · Class 2
Overview
| Product Code | EBI |
|---|---|
| Device Name | Resin, Denture, Relining, Repairing, Rebasing |
| Regulation | 21 CFR 872.3760 |
| Device Class | Class 2 |
| Review Panel | Dental |
| 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 | LuxCreo Flexible Partial Denture Resin | LuxCreo, Inc. | Nov 25, 2025 | SESE |
| K253681 | 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 | UltraPrint-Dental Denture UV | Guangzhou Heygears IMC., Inc. | Nov 20, 2025 | SESE |
| K252430 | Freeprint® denture flex | Detax GmbH | Oct 30, 2025 | SESE |
| K252035 | 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 | Flexible Partial Resin | Prismatik Dentalcraft, Inc. | Jun 25, 2025 | SESE |
| K242897 | Partial Flex | Clemde SA DE CV | Jun 3, 2025 | SESE |
| K250489 | FP3D | Keystone Industries | May 20, 2025 | SESE |
| K250617 | Apex Flex | Sprintray, Inc. | Apr 29, 2025 | SESE |
| K243356 | Asiga DentaBASE | Asiga Pty, Ltd. | Apr 11, 2025 | SESE |
| K250946 | Denture Base Resin DT20 | Hangzhou SHINING3D Dental Technology Co., Ltd. | Mar 31, 2025 | SESE |
| K243103 | Denture Base | Riton 3D Technology Co., Ltd. | Dec 23, 2024 | SESE |
| K243336 | Lucitone Digital Print Denture System | Dentsply Sirona, Inc. | Dec 17, 2024 | SESE |
| K242884 | Additively Manufactured Denture Resin | Aidite (Qinhuangdao) Technology Co., Ltd. | Nov 22, 2024 | SESE |
| K241089 | KeyPrint KeyDenture Base | Keystone Industries | Oct 24, 2024 | SESE |
| K241493 | Glidewell 3DP Denture Base Resin | Prismatik Dentalcraft, Inc. | Sep 12, 2024 | SESE |
| K241071 | NextDent Jet Denture Base; NextDent Jet Denture Teeth | Vertex-Dental B.V. | Sep 4, 2024 | SESE |
| K240688 | RODIN Titan 3D Resin | Belport Company, Inc., Gingi-Pak | Jun 20, 2024 | SESE |
| K233859 | BASIS FLOW II | YAMAHACHI DENTAL MFG., Co. | Mar 5, 2024 | SESE |
| K233995 | 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
