ULTRACROWN(TM) PD ALLOY POST-SOLDER
Device Facts
| Record ID | K913860 |
|---|---|
| Device Name | ULTRACROWN(TM) PD ALLOY POST-SOLDER |
| Applicant | Dentsply Intl. |
| Product Code | EJS · Dental |
| Decision Date | Nov 13, 1991 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 872.3060 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A noble metal alloy is a device composed primarily of noble metals, such as gold, palladium, platinum, or silver, that is intended for use in the fabrication of cast or porcelain-fused-to-metal crown and bridge restorations.
Special Controls
*Classification.* Class II (special controls). The special control for these devices is FDA's “Class II Special Controls Guidance Document: Dental Noble Metal Alloys.” The devices are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9. See § 872.1(e) for availability of guidance information.
