ARISTEE (RESIN, CROWN AND BRIDGES)
Device Facts
| Record ID | K900068 |
|---|---|
| Device Name | ARISTEE (RESIN, CROWN AND BRIDGES) |
| Applicant | Prometex, Inc. |
| Product Code | EBG · Dental |
| Decision Date | Apr 3, 1990 |
| 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.
