EBI — Resin, Denture, Relining, Repairing, Rebasing Class II
FDA product code EBI covers "Resin, Denture, Relining, Repairing, Rebasing", a Class II medical device regulated under 21 CFR 872.3760. Submissions are reviewed by the Dental panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- EBI
- Device Class
- Class II
- Regulation Number
- 872.3760
- Submission Type
- Review Panel
- DE
- Medical Specialty
- Dental
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K262300 | formlabs ohio | Denture Base Resin V2 | July 8, 2026 |
| K261474 | dentca | DENTCA Tru Flexible | July 1, 2026 |
| K260569 | carbon | DB 4000 High Impact Denture Base | June 2, 2026 |
| K260376 | shandong huge dental material corporation | Denture Base | May 6, 2026 |
| K253365 | luxcreo | LuxCreo Flexible Partial Denture Resin | November 25, 2025 |
| K253681 | graphy | TERA HARZ Hard Denture (THD-C-500); TERA HARZ Hard Denture (THD-C-1000); TERA HA | November 21, 2025 |
| K253324 | guangzhou heygears imc | UltraPrint-Dental Denture UV | November 20, 2025 |
| K252430 | detax | Freeprint® denture flex | October 30, 2025 |
| K252035 | kamemizu chemical industry co | DENTURE SOFT EX (Pink set); DENTURE SOFT EX (White set); DENTURE SOFT EX (Pink p | September 17, 2025 |
| K250302 | prismatik dentalcraft | Flexible Partial Resin | June 25, 2025 |
| K242897 | clemde sa de cv | Partial Flex | June 3, 2025 |
| K250489 | keystone industries | FP3D | May 20, 2025 |
| K250617 | sprintray | Apex Flex | April 29, 2025 |
| K243356 | asiga pty | Asiga DentaBASE | April 11, 2025 |
| K250946 | hangzhou shining3d dental technology co | Denture Base Resin DT20 | March 31, 2025 |
| K243103 | riton 3d technology co | Denture Base | December 23, 2024 |
| K243336 | dentsply sirona | Lucitone Digital Print Denture System | December 17, 2024 |
| K242884 | aidite (qinhuangdao) technology co | Additively Manufactured Denture Resin | November 22, 2024 |
| K241089 | keystone industries | KeyPrint KeyDenture Base | October 24, 2024 |
| K241493 | prismatik dentalcraft | Glidewell 3DP Denture Base Resin | September 12, 2024 |