ELN · Teeth, Preformed Gold Denture
Dental · 21 CFR 872.3580 · Class 1
Overview
| Product Code | ELN |
|---|---|
| Device Name | Teeth, Preformed Gold Denture |
| Regulation | 21 CFR 872.3580 |
| Device Class | Class 1 |
| Review Panel | Dental |
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.
Recent Cleared Devices (1 of 1)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K770872 | IMPRESSION MATERIAL, ALGINATE | Espe GmbH (Us) | Jun 1, 1977 | SESE |
Top Applicants
- Espe GmbH (Us) — 1 clearance
