EBG
- Product code
- EBG
- Device name
- Crown And Bridge, Temporary, Resin
- Device class
- Class 2
- 21 CFR
- 21 CFR 872.3770
- Medical specialty
- Dental
- Marketing pathway
- 510(K)
- Flag
- Third-party review eligible
- 510(k) clearances (last 3 years)
- 11
- Summaries archived here
- 10 (direct download)
- 510(k) clearances (all years, FDA)
- 189 (all years; only the last 3 years are listed here)
510(k) clearances, last 3 years (11)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K261261 | 2026-04-17 | Hangzhou SHINING3D Dental Technology C | Dura-Arch | |
| K253380 | 2026-03-02 | Liaoning Upcera Co., Ltd. | FLNT Base and FLNT Temp | |
| K251271 | 2025-06-23 | Rizhao Huge Biomaterials Company, Ltd. | TempFIT Temporary Crown and Bridge Resin | |
| K243370 | 2025-05-05 | Asiga Pty, Ltd. | DentaTOOTH | |
| K243621 | 2025-04-22 | Evoden Indústria Comércio Importação E | Evoblock, Perléon | — |
| K243951 | 2025-02-21 | Taiwan Dental Materials Co., Ltd. | TEMP MASTER, PMMA-based dental resin | |
| K242559 | 2024-11-26 | Sprintray, Inc. | Digital Temp | |
| K231859 | 2024-11-26 | Dentscare Ltda | PrimmaArt | |
| K240538 | 2024-07-19 | Formlabs Ohio, Inc. | Premium Teeth Resin | |
| K241226 | 2024-05-31 | Dreve Denatmid GmbH | Fixtemp® C&B 4:1 | |
| K233868 | 2024-05-23 | Kulzer, LLC | dima Print Teeth & Temp |
Official FDA classification page: EBG
Classification and pathway per current FDA publications. Data from openFDA (CC0).