HYDROXYLATE DENTAL COMPOSITE RESTROATIVE
Device Facts
| Record ID | K802535 |
|---|---|
| Device Name | HYDROXYLATE DENTAL COMPOSITE RESTROATIVE |
| Applicant | Wallace A. Erickson & Co. |
| Product Code | EBF · Dental |
| Decision Date | Dec 18, 1980 |
| 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.
