Title 21: Food and Drugs
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/ PART 872 - DENTAL DEVICES
/ Subpart D - Prosthetic Devices / § 872.3590 Preformed plastic denture tooth.
§ 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.