21 CFR 872.3710 — Alloy, Metal, Base
Dental (DE) · Subpart D—Prosthetic Devices · § 872.3710
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.
Classification Rationale
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.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| EJH | Alloy, Metal, Base | 2 | 153 |
Special Controls
EJH — Alloy, Metal, Base
*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.
eCFR
EJH — Alloy, Metal, Base
The special control for this device is FDA's “Class II Special Controls Guidance Document: Dental Base Metal Alloys.”
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