GC TEMPRON
Device Facts
| Record ID | K935960 |
|---|---|
| Device Name | GC TEMPRON |
| Applicant | GC America, Inc. |
| Product Code | EBG · Dental |
| Decision Date | Mar 4, 1994 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 872.3770 |
| Device Class | Class 2 |
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.