Dental

OFW · Restorative Instrument And Component Tray

Dental · 21 CFR 872.3690 · Class 2

Overview

Product CodeOFW
Device NameRestorative Instrument And Component Tray
Regulation21 CFR 872.3690
Device ClassClass 2
Review PanelDental

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.

Innolitics

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