ALTIS (RESIN, CROWN AND BRIDGES)
Device Facts
| Record ID | K902040 |
|---|---|
| Device Name | ALTIS (RESIN, CROWN AND BRIDGES) |
| Applicant | Pb2 Investment, Inc. |
| Product Code | EBF · Dental |
| Decision Date | Oct 9, 1990 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 872.3690 |
| Device Class | Class 2 |
Regulatory Classification
Identification
Tooth shade resin material is a device composed of materials such as bisphenol-A glycidyl methacrylate (Bis-GMA) intended to restore carious lesions or structural defects in teeth.
