EBI
- Product code
- EBI
- Device name
- Resin, Denture, Relining, Repairing, Rebasing
- Device class
- Class 2
- 21 CFR
- 21 CFR 872.3760
- Medical specialty
- Dental
- Marketing pathway
- 510(K)
- Flag
- Third-party review eligible
- 510(k) clearances (last 3 years)
- 30
- Summaries archived here
- 28 (direct download)
- 510(k) clearances (all years, FDA)
- 335 (all years; only the last 3 years are listed here)
510(k) clearances, last 3 years (30)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K261802 | 2026-08-27 | Prismatik Dentalcraft, Inc. | Glidewell Denture Base Resin | |
| K261626 | 2026-08-13 | Guangzhou Heygears IMC., Inc. | UltraPrint Flexible Denture UV | |
| K262681 | 2026-07-31 | 3BFAB TEKNOLOJI A.S. | NanoCeram Resin | |
| K262300 | 2026-07-08 | Formlabs Ohio, Inc. | Denture Base Resin V2 | |
| K261474 | 2026-07-01 | Dentca, Inc. | DENTCA Tru Flexible | |
| K260569 | 2026-06-02 | Carbon, Inc. | DB 4000 High Impact Denture Base | |
| K260376 | 2026-05-06 | Shandong Huge Dental Material Corporat… | Denture Base | |
| K253365 | 2025-11-25 | LuxCreo, Inc. | LuxCreo Flexible Partial Denture Resin | |
| K253681 | 2025-11-21 | Graphy, Inc. | TERA HARZ Hard Denture (THD-C-500); TERA HARZ Hard D… | |
| K253324 | 2025-11-20 | Guangzhou Heygears IMC., Inc. | UltraPrint-Dental Denture UV | |
| K252430 | 2025-10-30 | Detax GmbH | Freeprint® denture flex | FDA |
| K252035 | 2025-09-17 | Kamemizu Chemical Industry Co., Ltd. | DENTURE SOFT EX (Pink set); DENTURE SOFT EX (White s… | |
| K250302 | 2025-06-25 | Prismatik Dentalcraft, Inc. | Flexible Partial Resin | |
| K242897 | 2025-06-03 | Clemde SA DE CV | Partial Flex | |
| K250489 | 2025-05-20 | Keystone Industries | FP3D | |
| K250617 | 2025-04-29 | Sprintray, Inc. | Apex Flex | |
| K243356 | 2025-04-11 | Asiga Pty, Ltd. | Asiga DentaBASE | |
| K250946 | 2025-03-31 | Hangzhou SHINING3D Dental Technology C… | Denture Base Resin DT20 | |
| K243103 | 2024-12-23 | Riton 3D Technology Co., Ltd. | Denture Base | |
| K243336 | 2024-12-17 | Dentsply Sirona, Inc. | Lucitone Digital Print Denture System | |
| K242884 | 2024-11-22 | Aidite (Qinhuangdao) Technology Co., L… | Additively Manufactured Denture Resin | |
| K241089 | 2024-10-24 | Keystone Industries | KeyPrint KeyDenture Base | FDA |
| K241493 | 2024-09-12 | Prismatik Dentalcraft, Inc. | Glidewell 3DP Denture Base Resin | |
| K241071 | 2024-09-04 | Vertex-Dental B.V. | NextDent Jet Denture Base; NextDent Jet Denture Teet… | |
| K240688 | 2024-06-20 | Belport Company, Inc., Gingi-Pak | RODIN Titan 3D Resin | |
| K233859 | 2024-03-05 | YAMAHACHI DENTAL MFG., Co. | BASIS FLOW II | |
| K233995 | 2024-02-23 | Ivoclar Vivadent, Inc. | Ivotion Base Print | |
| K233171 | 2023-11-27 | Clemde SA DE CV | PF Keep; Cad Cam Keep Block | |
| K231388 | 2023-10-20 | Vertex-Dental B.V. | NextDent Base | |
| K231578 | 2023-10-20 | Dentsply Sirona | Lucitone Digital Print Denture System |
Official FDA classification page: EBI
Classification and pathway per current FDA publications. Data from openFDA (CC0).