EBG · Crown And Bridge, Temporary, Resin
Dental · 21 CFR 872.3770 · Class 2
Overview
| Product Code | EBG |
|---|---|
| Device Name | Crown And Bridge, Temporary, Resin |
| Regulation | 21 CFR 872.3770 |
| Device Class | Class 2 |
| Review Panel | Dental |
| 3rd-Party Reviewable | Yes |
Identification
A temporary crown and bridge resin is a device composed of a material, such as polymethylmethacrylate, intended to make a temporary prosthesis, such as a crown or bridge, for use until a permanent restoration is fabricated.
Classification Rationale
Class II.
Recent Cleared Devices (20 of 189)
Showing 20 most recent of 189 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K261261 | Dura-Arch | Hangzhou SHINING3D Dental Technology Co., Ltd. | Apr 17, 2026 | SESE |
| K253380 | FLNT Base and FLNT Temp | Liaoning Upcera Co., Ltd. | Mar 2, 2026 | SESE |
| K251271 | TempFIT Temporary Crown and Bridge Resin | Rizhao Huge Biomaterials Company, Ltd. | Jun 23, 2025 | SESE |
| K243370 | DentaTOOTH | Asiga Pty, Ltd. | May 5, 2025 | SESE |
| K243621 | Evoblock, Perléon | Evoden Indústria Comércio Importação E Exportação | Apr 22, 2025 | SESE |
| K243951 | TEMP MASTER, PMMA-based dental resin | Taiwan Dental Materials Co., Ltd. | Feb 21, 2025 | SESE |
| K242559 | Digital Temp | Sprintray, Inc. | Nov 26, 2024 | SESE |
| K231859 | PrimmaArt | Dentscare Ltda | Nov 26, 2024 | SESE |
| K240538 | Premium Teeth Resin | Formlabs Ohio, Inc. | Jul 19, 2024 | SESE |
| K241226 | Fixtemp® C&B 4:1 | Dreve Denatmid GmbH | May 31, 2024 | SESE |
| K233868 | dima Print Teeth & Temp | Kulzer, LLC | May 23, 2024 | SESE |
| K223706 | PMMA BLOCK | Huliang(Shanghai) Bio-Tech Co., Ltd. | May 12, 2023 | SESE |
| K223477 | PMMA Blocks for Dental Use | Aidite (Qinhuangdao) Technology Co., Ltd. | Feb 16, 2023 | SESE |
| K202965 | CURA-Temp | Mgnewton , Ltd. | Dec 21, 2022 | SESE |
| K214071 | Hexa-Temp | Spident Co., Ltd. | Mar 10, 2022 | SESE |
| K213643 | UltraPrint-Dental Temp C&B UV | Guangzhou Heygears IMC., Inc. | Jan 14, 2022 | SESE |
| K210817 | C&B 5.0 Hybrid | Arum Dentistry Co., Ltd. | Dec 8, 2021 | SESE |
| K211101 | E-Temp | Envisiontec GmbH | Jun 14, 2021 | SESE |
| K201563 | PuRE PMMA Disc | Quest Dental USA Corp. | Apr 9, 2021 | SESE |
| K190217 | Aidite PMMA | Aidite (Qinhuangdao) Technology Co., Ltd. | Dec 17, 2020 | SESE |
Top Applicants
- GC America, Inc. — 6 clearances
- Ivoclar Vivadent, Inc. — 6 clearances
- Sybron Dental Specialties, Inc. — 6 clearances
- Dmg USA, Inc. — 5 clearances
- Voco GmbH — 5 clearances
