CHALLENGER DIRECT COMPOSITE
Device Facts
| Record ID | K010219 |
|---|---|
| Device Name | CHALLENGER DIRECT COMPOSITE |
| Applicant | International Dental Research |
| Product Code | EBF · Dental |
| Decision Date | Feb 21, 2001 |
| Decision | SESE |
| Submission Type | Special |
| 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.
