VITALLIUM EQUIPOISE ALLOY
Device Facts
| Record ID | K880875 |
|---|---|
| Device Name | VITALLIUM EQUIPOISE ALLOY |
| Applicant | Austenal Dental, Inc. |
| Product Code | EJH · Dental |
| Decision Date | Apr 7, 1988 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 872.3710 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A base metal alloy is a device composed primarily of base metals, such as nickel, chromium, or cobalt, that is intended for use in fabrication of cast or porcelain-fused-to-metal crown and bridge restorations.
Special Controls
*Classification.* Class II (special controls). The special control for this device is FDA's “Class II Special Controls Guidance Document: Dental Base Metal Alloys.” 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. See § 872.1(e) for availability of guidance information.
