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e-CFR data is current as of March 2, 2021

Title 21Chapter ISubchapter HPart 872Subpart D → §872.3710


Title 21: Food and Drugs
PART 872—DENTAL DEVICES
Subpart D—Prosthetic Devices


§872.3710   Base metal alloy.

(a) 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.

(b) 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.

[69 FR 51766, Aug. 23, 2004]

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