ARGI-SATIN OR OPTI0-STAR
Device Facts
| Record ID | K965216 |
|---|---|
| Device Name | ARGI-SATIN OR OPTI0-STAR |
| Applicant | Argen Precious Metals, Inc. |
| Product Code | ELL · Dental |
| Decision Date | Feb 27, 1997 |
| 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.
