EBG — Crown And Bridge, Temporary, Resin Class II
FDA product code EBG covers "Crown And Bridge, Temporary, Resin", a Class II medical device regulated under 21 CFR 872.3770. Submissions are reviewed by the Dental panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- EBG
- Device Class
- Class II
- Regulation Number
- 872.3770
- Submission Type
- Review Panel
- DE
- Medical Specialty
- Dental
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K261261 | hangzhou shining3d dental technology co | Dura-Arch | April 17, 2026 |
| K253380 | liaoning upcera co | FLNT Base and FLNT Temp | March 2, 2026 |
| K251271 | rizhao huge biomaterials company | TempFIT Temporary Crown and Bridge Resin | June 23, 2025 |
| K243370 | asiga pty | DentaTOOTH | May 5, 2025 |
| K243621 | evoden indústria comércio importação e exportação | Evoblock, Perléon | April 22, 2025 |
| K243951 | taiwan dental materials co | TEMP MASTER, PMMA-based dental resin | February 21, 2025 |
| K242559 | sprintray | Digital Temp | November 26, 2024 |
| K231859 | dentscare ltda | PrimmaArt | November 26, 2024 |
| K240538 | formlabs ohio | Premium Teeth Resin | July 19, 2024 |
| K241226 | dreve denatmid | Fixtemp® C&B 4:1 | May 31, 2024 |
| K233868 | kulzer | dima Print Teeth & Temp | May 23, 2024 |
| K223706 | huliang(shanghai) bio-tech co | PMMA BLOCK | May 12, 2023 |
| K223477 | aidite (qinhuangdao) technology co | PMMA Blocks for Dental Use | February 16, 2023 |
| K202965 | mgnewton | CURA-Temp | December 21, 2022 |
| K214071 | spident co | Hexa-Temp | March 10, 2022 |
| K213643 | guangzhou heygears imc | UltraPrint-Dental Temp C&B UV | January 14, 2022 |
| K210817 | arum dentistry co | C&B 5.0 Hybrid | December 8, 2021 |
| K211101 | envisiontec | E-Temp | June 14, 2021 |
| K201563 | quest dental usa | PuRE PMMA Disc | April 9, 2021 |
| K190217 | aidite (qinhuangdao) technology co | Aidite PMMA | December 17, 2020 |