21 CFR 872.3200 — Agent, Tooth Bonding, Resin

Dental (DE) · Subpart D—Prosthetic Devices · § 872.3200

Identification

A resin tooth bonding agent is a device material, such as methylmethacrylate, intended to be painted on the interior of a prepared cavity of a tooth to improve retention of a restoration, such as a filling.

Classification Rationale

Class II.

Product Codes

Product CodeDevice NameClassDevicesAttributes
KLEAgent, Tooth Bonding, Resin24183rd Party
Innolitics

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