Preformed gold denture tooth.

21 C.F.R. § 872.3580
in effectEffective: 2024-07-01
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(a) Identification. A preformed gold denture tooth is a device composed of austenitic alloys or alloys containing 75 percent or greater gold and metals of the platinum group intended for use as a tooth or a portion of a tooth in a fixed or removable partial denture. (b) Classification. Class I (general 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.

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