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 |
|---|---|---|---|
| 06942201747398 | FLNT Temp | Liaoning Upcera Co.,Ltd. | 2026-05-26 |
| 06942201747404 | FLNT Temp | Liaoning Upcera Co.,Ltd. | 2026-05-26 |
| 06942201747497 | FLNT Temp | Liaoning Upcera Co.,Ltd. | 2026-05-26 |
| 06942201747589 | FLNT Temp | Liaoning Upcera Co.,Ltd. | 2026-05-26 |
| 06942201747596 | FLNT Temp | Liaoning Upcera Co.,Ltd. | 2026-05-26 |
| 06942201747688 | FLNT Temp | Liaoning Upcera Co.,Ltd. | 2026-05-26 |
| 06942201747695 | FLNT Temp | Liaoning Upcera Co.,Ltd. | 2026-05-26 |
| 06942201747701 | FLNT Temp | Liaoning Upcera Co.,Ltd. | 2026-05-26 |
| 06942201747886 | FLNT Temp | Liaoning Upcera Co.,Ltd. | 2026-05-26 |
| 06942201747978 | FLNT Temp | Liaoning Upcera Co.,Ltd. | 2026-05-26 |
| 06942201747329 | FLNT Temp | Liaoning Upcera Co.,Ltd. | 2026-05-26 |
| 06942201747206 | FLNT Temp | Liaoning Upcera Co.,Ltd. | 2026-05-22 |
| 06942201747305 | FLNT Temp | Liaoning Upcera Co.,Ltd. | 2026-05-22 |
| 06942201747190 | FLNT Temp | Liaoning Upcera Co.,Ltd. | 2026-05-22 |
| 06942201747114 | FLNT Temp | Liaoning Upcera Co.,Ltd. | 2026-05-22 |
| 06942201747015 | FLNT Temp | Liaoning Upcera Co.,Ltd. | 2026-05-22 |
| 06942201746728 | FLNT Temp | Liaoning Upcera Co.,Ltd. | 2026-05-22 |
| 08800055726946 | C&B 5.0 Hybrid | ARUM DENTISTRY Co., Ltd. | 2026-03-10 |
| 08800055726953 | C&B 5.0 Hybrid | ARUM DENTISTRY Co., Ltd. | 2026-03-10 |
| 06971437944158 | UltraPrint Temp C&B UV | GUANGZHOU HEYGEARS IMC.INC | 2026-03-04 |
| 06971437944165 | UltraPrint Temp C&B UV | GUANGZHOU HEYGEARS IMC.INC | 2026-03-04 |
| 06971437944172 | UltraPrint Temp C&B UV | GUANGZHOU HEYGEARS IMC.INC | 2026-03-04 |
| 06971437944189 | UltraPrint Temp C&B UV | GUANGZHOU HEYGEARS IMC.INC | 2026-03-04 |
| 06971437944196 | UltraPrint Temp C&B UV | GUANGZHOU HEYGEARS IMC.INC | 2026-03-04 |
| E235DD18A1ML0 | DENTADISC | SHOFU DENTAL CORPORATION | 2026-01-25 |
| E235DD18A1MN0 | DENTADISC | SHOFU DENTAL CORPORATION | 2026-01-25 |
| E235DD18A2ML0 | DENTADISC | SHOFU DENTAL CORPORATION | 2026-01-25 |
| E235DD18A2MN0 | DENTADISC | SHOFU DENTAL CORPORATION | 2026-01-25 |
| E235DD18A35MN0 | DENTADISC | SHOFU DENTAL CORPORATION | 2026-01-25 |
| E235DD18A3ML0 | DENTADISC | SHOFU DENTAL CORPORATION | 2026-01-25 |