AMELOGEN RESTORATIVE MATERIALS
Device Facts
| Record ID | K932227 |
|---|---|
| Device Name | AMELOGEN RESTORATIVE MATERIALS |
| Applicant | Ultradent Products, Inc. |
| Product Code | EBF · Dental |
| Decision Date | Sep 13, 1993 |
| 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.
