DUCERAGOLD, DUCERATIN
Device Facts
| Record ID | K931808 |
|---|---|
| Device Name | DUCERAGOLD, DUCERATIN |
| Applicant | Degussa AG |
| Product Code | ELL · Dental |
| Decision Date | Nov 3, 1993 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 872.3920 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A porcelain tooth is a prefabricated device made of porcelain powder for clinical use (§ 872.6660) intended for use in construction of fixed or removable prostheses, such as crowns and partial dentures.