Product code EBG
- Device name
- Crown And Bridge, Temporary, Resin
- Medical specialty
- Dental
- Device class
- 2
- Regulation number
- 872.3770
- 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 |
|---|---|---|---|
| K261261 | Dura-Arch | Hangzhou SHINING3D Dental Technology Co., Ltd. | 2026-04-17 |
| K253380 | “FLNT Base” and “FLNT Temp” | Liaoning Upcera Co., Ltd. | 2026-03-02 |
| K251271 | TempFIT Temporary Crown and Bridge Resin | Rizhao Huge Biomaterials Company, Ltd. | 2025-06-23 |
| K243370 | DentaTOOTH | Asiga Pty, Ltd. | 2025-05-05 |
| K243621 | Evoblock, Perléon | Evoden Indústria Comércio Importação E Exportação | 2025-04-22 |
| K243951 | TEMP MASTER, PMMA-based dental resin | Taiwan Dental Materials Co., Ltd. | 2025-02-21 |
| K242559 | Digital Temp | Sprintray, Inc. | 2024-11-26 |
| K231859 | PrimmaArt | Dentscare Ltda | 2024-11-26 |
| K240538 | Premium Teeth Resin | Formlabs Ohio, Inc. | 2024-07-19 |
| K241226 | Fixtemp® C&B 4:1 | Dreve Denatmid GmbH | 2024-05-31 |
| K233868 | dima Print Teeth & Temp | Kulzer, LLC | 2024-05-23 |
| K223706 | PMMA BLOCK | Huliang(Shanghai) Bio-Tech Co., Ltd. | 2023-05-12 |
| K223477 | PMMA Blocks for Dental Use | Aidite (Qinhuangdao) Technology Co., Ltd. | 2023-02-16 |
| K202965 | CURA-Temp | Mgnewton , Ltd. | 2022-12-21 |
| K214071 | Hexa-Temp | Spident Co., Ltd. | 2022-03-10 |
| K213643 | UltraPrint-Dental Temp C&B UV | Guangzhou Heygears IMC., Inc. | 2022-01-14 |
| K210817 | C&B 5.0 Hybrid | Arum Dentistry Co., Ltd. | 2021-12-08 |
| K211101 | E-Temp | Envisiontec GmbH | 2021-06-14 |
| K201563 | PuRE PMMA Disc | Quest Dental USA Corp. | 2021-04-09 |
| K190217 | Aidite PMMA | Aidite (Qinhuangdao) Technology Co., Ltd. | 2020-12-17 |
| K201827 | GR-17 Resin System | Pro3Dure Medical GmbH | 2020-11-05 |
| K201683 | PMMA Block | Huge Dental Material Co., Ltd. | 2020-11-03 |
| K200273 | FREEPRINT temp | Detax GmbH & Co. KG | 2020-10-27 |
| K201090 | Structur CAD | Voco GmbH | 2020-09-09 |
| K192830 | Bright Temporary C&B | Dmp Dental Industry S.A. | 2020-09-02 |
| K200039 | P pro Crown & Bridge | Deltamed GmbH | 2020-07-31 |
| K193113 | GC Temp Print | GC America, Inc. | 2020-07-09 |
| K200676 | ABRO 1, RESITON GINGIVA, PRIME and THERAPON TRANSPA | Zirkonzahn Srl | 2020-07-08 |
| K193553 | VarseoSmile Temp | Bego Bremer Goldschlagerei Wilh. Herbst GmbH & Co. KG | 2020-05-18 |
| K191590 | AA temp temporary restoration 3D printing photoreactive resin | Enlighten Materials Co., Ltd. | 2020-05-05 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| EPOLKML207200 | DD poly Y ML | POLIDENT d.o.o. | 2024-10-02 |
| EPOLKML214200 | DD poly Y ML | POLIDENT d.o.o. | 2024-10-02 |
| EPOLKML214160 | DD poly Y ML | POLIDENT d.o.o. | 2024-10-02 |
| EPOLKML213200 | DD poly Y ML | POLIDENT d.o.o. | 2024-10-02 |
| EPOLKML213160 | DD poly Y ML | POLIDENT d.o.o. | 2024-10-02 |
| EPOLKML212200 | DD poly Y ML | POLIDENT d.o.o. | 2024-10-02 |
| EPOLKML212160 | DD poly Y ML | POLIDENT d.o.o. | 2024-10-02 |
| EPOLKML211200 | DD poly Y ML | POLIDENT d.o.o. | 2024-10-02 |
| EPOLKML211160 | DD poly Y ML | POLIDENT d.o.o. | 2024-10-02 |
| EPOLKML210200 | DD poly Y ML | POLIDENT d.o.o. | 2024-10-02 |
| EPOLKML210160 | DD poly Y ML | POLIDENT d.o.o. | 2024-10-02 |
| EPOLKML209200 | DD poly Y ML | POLIDENT d.o.o. | 2024-10-02 |
| EPOLKML209160 | DD poly Y ML | POLIDENT d.o.o. | 2024-10-02 |
| EPOLKML208200 | DD poly Y ML | POLIDENT d.o.o. | 2024-10-02 |
| EPOLKML208160 | DD poly Y ML | POLIDENT d.o.o. | 2024-10-02 |
| EPOLKML200160 | DD poly Y ML | POLIDENT d.o.o. | 2024-10-02 |
| EPOLKML207160 | DD poly Y ML | POLIDENT d.o.o. | 2024-10-02 |
| EPOLKML206200 | DD poly Y ML | POLIDENT d.o.o. | 2024-10-02 |
| EPOLKML206160 | DD poly Y ML | POLIDENT d.o.o. | 2024-10-02 |
| EPOLKML205200 | DD poly Y ML | POLIDENT d.o.o. | 2024-10-02 |
| EPOLKML205160 | DD poly Y ML | POLIDENT d.o.o. | 2024-10-02 |
| EPOLKML204200 | DD poly Y ML | POLIDENT d.o.o. | 2024-10-02 |
| EPOLKML204160 | DD poly Y ML | POLIDENT d.o.o. | 2024-10-02 |
| EPOLKML203200 | DD poly Y ML | POLIDENT d.o.o. | 2024-10-02 |
| EPOLKML203160 | DD poly Y ML | POLIDENT d.o.o. | 2024-10-02 |
| EPOLKML202200 | DD poly Y ML | POLIDENT d.o.o. | 2024-10-02 |
| EPOLKML202160 | DD poly Y ML | POLIDENT d.o.o. | 2024-10-02 |
| EPOLKML201200 | DD poly Y ML | POLIDENT d.o.o. | 2024-10-02 |
| EPOLKML201160 | DD poly Y ML | POLIDENT d.o.o. | 2024-10-02 |
| EPOLKML200200 | DD poly Y ML | POLIDENT d.o.o. | 2024-10-02 |