21 CFR 872.3310 — Coating, Filling Material, Resin
Dental (DE) · Subpart D—Prosthetic Devices · § 872.3310
Identification
A coating material for resin fillings is a device intended to be applied to the surface of a restorative resin dental filling to attain a smooth, glaze-like finish on the surface of the filling.
Classification Rationale
Class II.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| EBD | Coating, Filling Material, Resin | 2 | 52 | 3rd Party |