21 CFR 872.3690 — Material, Tooth Shade, Resin

Dental (DE) · Subpart D—Prosthetic Devices · § 872.3690

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.

Product Codes

Product CodeDevice NameClassDevicesAttributes
EBFMaterial, Tooth Shade, Resin29243rd Party
OFWRestorative Instrument And Component Tray20
Innolitics

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