LUXAFORM
Device Facts
| Record ID | K000951 |
|---|---|
| Device Name | LUXAFORM |
| Applicant | Dmg USA, Inc. |
| Product Code | EBG · Dental |
| Decision Date | Apr 5, 2000 |
| 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.