Product code EBI
- Device name
- Resin, Denture, Relining, Repairing, Rebasing
- Medical specialty
- Dental
- Device class
- 2
- Regulation number
- 872.3760
- Review panel
- DE
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K260569 | DB 4000 High Impact Denture Base | Carbon, Inc. | 2026-06-02 |
| K260376 | Denture Base | Shandong Huge Dental Material Corporation | 2026-05-06 |
| K253365 | LuxCreo Flexible Partial Denture Resin | LuxCreo, Inc. | 2025-11-25 |
| 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 D... | Graphy, Inc. | 2025-11-21 |
| K253324 | UltraPrint-Dental Denture UV | Guangzhou Heygears IMC., Inc. | 2025-11-20 |
| K252430 | Freeprint® denture flex | Detax GmbH | 2025-10-30 |
| 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. | 2025-09-17 |
| K250302 | Flexible Partial Resin | Prismatik Dentalcraft, Inc. | 2025-06-25 |
| K242897 | Partial Flex | Clemde SA DE CV | 2025-06-03 |
| K250489 | FP3D | Keystone Industries | 2025-05-20 |
| K250617 | Apex Flex | Sprintray, Inc. | 2025-04-29 |
| K243356 | Asiga DentaBASE | Asiga Pty, Ltd. | 2025-04-11 |
| K250946 | Denture Base Resin DT20 | Hangzhou SHINING3D Dental Technology Co., Ltd. | 2025-03-31 |
| K243103 | Denture Base | Riton 3D Technology Co., Ltd. | 2024-12-23 |
| K243336 | Lucitone Digital Print Denture™ System | Dentsply Sirona, Inc. | 2024-12-17 |
| K242884 | Additively Manufactured Denture Resin | Aidite (Qinhuangdao) Technology Co., Ltd. | 2024-11-22 |
| K241089 | KeyPrint KeyDenture Base | Keystone Industries | 2024-10-24 |
| K241493 | Glidewell™ 3DP Denture Base Resin | Prismatik Dentalcraft, Inc. | 2024-09-12 |
| K241071 | NextDent Jet Denture Base; NextDent Jet Denture Teeth | Vertex-Dental B.V. | 2024-09-04 |
| K240688 | RODIN Titan 3D Resin | Belport Company, Inc., Gingi-Pak | 2024-06-20 |
| K233859 | BASIS FLOW II | YAMAHACHI DENTAL MFG., Co. | 2024-03-05 |
| K233995 | Ivotion Base Print | Ivoclar Vivadent, Inc. | 2024-02-23 |
| K233171 | PF Keep; Cad Cam Keep Block | Clemde SA DE CV | 2023-11-27 |
| K231578 | Lucitone Digital Print Denture System | Dentsply Sirona | 2023-10-20 |
| K231388 | NextDent Base | Vertex-Dental B.V. | 2023-10-20 |
| K232691 | Polibond | Zirkonzahn Srl | 2023-09-05 |
| K231389 | Harvest Dental HD Gum Strip | Harvest Dental Products, LLC | 2023-08-16 |
| K230445 | OnX Tough | Sprintray, Inc. | 2023-07-14 |
| K230410 | DD medical polymers (PMMA) | Dental Direkt GmbH | 2023-06-23 |
| K222489 | Harvest Printable Resin | Harvest Dental Products, LLC | 2023-05-12 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| D14307560147448040 | Smart Dent ® | MMTECH PROJETOS TECNOLOGICOS IMPORTACAO E EXPORTACAO LTDA. | 2026-05-29 |
| D14307560147448110 | Smart Dent ® | MMTECH PROJETOS TECNOLOGICOS IMPORTACAO E EXPORTACAO LTDA. | 2026-05-29 |
| D14307560147448280 | Smart Dent ® | MMTECH PROJETOS TECNOLOGICOS IMPORTACAO E EXPORTACAO LTDA. | 2026-05-29 |
| D14307560147448350 | Smart Dent ® | MMTECH PROJETOS TECNOLOGICOS IMPORTACAO E EXPORTACAO LTDA. | 2026-05-29 |
| D14307560147449650 | Smart Dent ® | MMTECH PROJETOS TECNOLOGICOS IMPORTACAO E EXPORTACAO LTDA. | 2026-05-29 |
| D14307560147450090 | Smart Dent ® | MMTECH PROJETOS TECNOLOGICOS IMPORTACAO E EXPORTACAO LTDA. | 2026-05-29 |
| D14307560147450160 | Smart Dent ® | MMTECH PROJETOS TECNOLOGICOS IMPORTACAO E EXPORTACAO LTDA. | 2026-05-29 |
| D14307560147451840 | Smart Dent ® | MMTECH PROJETOS TECNOLOGICOS IMPORTACAO E EXPORTACAO LTDA. | 2026-05-29 |
| EPOLPMMP10180 | Pink CAD/CAM Disc | POLIDENT d.o.o. | 2024-10-17 |
| EPOLPMMP4820 | Pink CAD/CAM Disc | POLIDENT d.o.o. | 2024-10-17 |
| EPOLPMMP10190 | Pink CAD/CAM Disc | POLIDENT d.o.o. | 2024-10-17 |
| EPOLPMMP10200 | Pink CAD/CAM Disc | POLIDENT d.o.o. | 2024-10-17 |
| EPOLPMMP10210 | Pink CAD/CAM Disc | POLIDENT d.o.o. | 2024-10-17 |
| EPOLPMMP10220 | Pink CAD/CAM Disc | POLIDENT d.o.o. | 2024-10-17 |
| EPOLPMMP10230 | Pink CAD/CAM Disc | POLIDENT d.o.o. | 2024-10-17 |
| EPOLPMMP10240 | Pink CAD/CAM Disc | POLIDENT d.o.o. | 2024-10-17 |
| EPOLPMMP10250 | Pink CAD/CAM Disc | POLIDENT d.o.o. | 2024-10-17 |
| EPOLPMMP4810 | Pink CAD/CAM Disc | POLIDENT d.o.o. | 2024-10-17 |
| EPOLPMMP10170 | Pink CAD/CAM Disc | POLIDENT d.o.o. | 2024-10-17 |
| EPOLPMMP10160 | Pink CAD/CAM Disc | POLIDENT d.o.o. | 2024-10-17 |
| EPOLPMMP10150 | Pink CAD/CAM Disc | POLIDENT d.o.o. | 2024-10-17 |
| EPOLPMMP10140 | Pink CAD/CAM Disc | POLIDENT d.o.o. | 2024-10-17 |
| EPOLPMMP10130 | Pink CAD/CAM Disc | POLIDENT d.o.o. | 2024-10-17 |
| EPOLPMMP10120 | Pink CAD/CAM Disc | POLIDENT d.o.o. | 2024-10-17 |
| EPOLPMMP10110 | Pink CAD/CAM Disc | POLIDENT d.o.o. | 2024-10-17 |
| EPOLPMMP10100 | Pink CAD/CAM Disc | POLIDENT d.o.o. | 2024-10-17 |
| EPOLPMMP10090 | Pink CAD/CAM Disc | POLIDENT d.o.o. | 2024-10-17 |
| EPOLPMMP481 | Pink CAD/CAM Disc | POLIDENT d.o.o. | 2021-06-15 |
| EPOLPMMP482 | Pink CAD/CAM Disc | POLIDENT d.o.o. | 2021-06-15 |
| 07630031739704 | JUVORA Dental Disc, Ceramill PEEK by JUVORA | Institut Straumann AG | 2019-08-23 |