IMPRESSION MATERIAL, ALGINATE
Device Facts
| Record ID | K770872 |
|---|---|
| Device Name | IMPRESSION MATERIAL, ALGINATE |
| Applicant | Espe GmbH (Us) |
| Product Code | ELN · Dental |
| Decision Date | Jun 1, 1977 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 872.3580 |
| Device Class | Class 1 |
Regulatory Classification
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.
