DURAFILL MICROFILL RESTORATIVE MATERIAL
Device Facts
| Record ID | K811669 |
|---|---|
| Device Name | DURAFILL MICROFILL RESTORATIVE MATERIAL |
| Applicant | Kulzer, Inc. |
| Product Code | EBF · Dental |
| Decision Date | Jul 1, 1981 |
| 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.
