SIGNUM
Device Facts
| Record ID | K001360 |
|---|---|
| Device Name | SIGNUM |
| Applicant | J.F. Jelenko & Co., Inc. |
| Product Code | EBF · Dental |
| Decision Date | Jun 20, 2000 |
| 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.
