EBI — Resin, Denture, Relining, Repairing, Rebasing Class II
FDA Device Classification
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 |
|---|
| 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 |
| K241071 | vertex-dental | NextDent Jet Denture Base; NextDent Jet Denture Teeth | September 4, 2024 |
| K240688 | belport company, inc., gingi-pak | RODIN Titan 3D Resin | June 20, 2024 |
| K233859 | yamahachi dental mfg | BASIS FLOW II | March 5, 2024 |
| K233995 | ivoclar vivadent | Ivotion Base Print | February 23, 2024 |