21 CFR 872.3750 — Adhesive, Bracket And Tooth Conditioner, Resin
Dental (DE) · Subpart D—Prosthetic Devices · § 872.3750
Identification
A bracket adhesive resin and tooth conditioner is a device composed of an adhesive compound, such as polymethylmethacrylate, intended to cement an orthodontic bracket to a tooth surface.
Classification Rationale
Class II.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| DYH | Adhesive, Bracket And Tooth Conditioner, Resin | 2 | 192 | 3rd Party |
| KZP | Solution, Cement Dissolving | 2 | 2 | 3rd Party |