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 |
|---|---|---|---|
| K261802 | Prismatik Dentalcraft | Glidewell Denture Base Resin | Aug 27, 2026 |
| K261626 | Guangzhou Heygears Imc | UltraPrint Flexible Denture UV | Aug 13, 2026 |
| K262681 | 3Bfab Teknoloji A.S | NanoCeram Resin | Jul 31, 2026 |
| K262300 | Formlabs Ohio | Denture Base Resin V2 | Jul 8, 2026 |
| K261474 | Dentca | DENTCA Tru Flexible | Jul 1, 2026 |
| K260569 | Carbon | DB 4000 High Impact Denture Base | Jun 2, 2026 |
| K260376 | Shandong Huge Dental Material Corporation | Denture Base | May 6, 2026 |
| K253365 | Luxcreo | LuxCreo Flexible Partial Denture Resin | Nov 25, 2025 |
| K253681 | Graphy | TERA HARZ Hard Denture (THD-C-500); TERA HARZ Hard Denture (THD-C-1000); TERA HA | Nov 21, 2025 |
| K253324 | Guangzhou Heygears Imc | UltraPrint-Dental Denture UV | Nov 20, 2025 |
| K252430 | Detax | Freeprint® denture flex | Oct 30, 2025 |
| K252035 | Kamemizu Chemical Industry Co | DENTURE SOFT EX (Pink set); DENTURE SOFT EX (White set); DENTURE SOFT EX (Pink p | Sep 17, 2025 |
| K250302 | Prismatik Dentalcraft | Flexible Partial Resin | Jun 25, 2025 |
| K242897 | Clemde Sa De Cv | Partial Flex | Jun 3, 2025 |
| K250489 | Keystone Industries | FP3D | May 20, 2025 |
| K250617 | Sprintray | Apex Flex | Apr 29, 2025 |
| K243356 | Asiga Pty | Asiga DentaBASE | Apr 11, 2025 |
| K250946 | Hangzhou Shining3D Dental Technology Co | Denture Base Resin DT20 | Mar 31, 2025 |
| K243103 | Riton 3D Technology Co | Denture Base | Dec 23, 2024 |
| K243336 | Dentsply Sirona | Lucitone Digital Print Denture System | Dec 17, 2024 |