21 CFR 872.3910 — Teeth, Artificial, Backing And Facing
Dental (DE) · Subpart D—Prosthetic Devices · § 872.3910
Identification
A backing and facing for an artificial tooth is a device intended for use in fabrication of a fixed or removable dental appliance, such as a crown or bridge. The backing, which is made of gold, is attached to the dental appliance and supports the tooth-colored facing, which is made of porcelain or plastic.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| ELK | Teeth, Artificial, Backing And Facing | 1 | 2 |