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e-CFR data is current as of February 24, 2021

Title 21Chapter ISubchapter HPart 872Subpart D → §872.3590


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


§872.3590   Preformed plastic denture tooth.

(a) Identification. A preformed plastic denture tooth is a prefabricated device, composed of materials such as methyl methacrylate, that is intended for use as a tooth in a denture.

(b) Classification. Class II (special controls). 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.

[52 FR 30097, Aug. 12, 1987, as amended at 84 FR 71812, Dec. 30, 2019]

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