Dura-Arch
Device Facts
| Record ID | K261261 |
|---|---|
| Device Name | Dura-Arch |
| Applicant | Hangzhou SHINING3D Dental Technology Co., Ltd. |
| Product Code | EBG · Dental |
| Decision Date | Apr 17, 2026 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 872.3770 |
| Device Class | Class 2 |
| Attributes | 3rd-Party Reviewed |
Regulatory Classification
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.
