21 CFR 872.3580 — Teeth, Preformed Gold Denture
Dental (DE) · Subpart D—Prosthetic Devices · § 872.3580
Identification
A preformed gold denture tooth is a device composed of austenitic alloys or alloys containing 75 percent or greater gold and metals of the platinum group intended for use as a tooth or a portion of a tooth in a fixed or removable partial denture.
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 |
|---|---|---|---|---|
| ELN | Teeth, Preformed Gold Denture | 1 | 1 |
