OFW · Restorative Instrument And Component Tray
Dental · 21 CFR 872.3690 · Class 2
Overview
| Product Code | OFW |
|---|---|
| Device Name | Restorative Instrument And Component Tray |
| Regulation | 21 CFR 872.3690 |
| Device Class | Class 2 |
| Review Panel | Dental |
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.
Classification Rationale
Class II.
Cleared Devices (0)
No cleared devices on record.