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 Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| KLE | Agent, Tooth Bonding, Resin | 2 | 418 | 3rd Party |