StacksVerified U.S. regulatory reference

21 CFR §872.3580

Verified against eCFR.gov as of June 20, 2026View official text on eCFR.gov ↗
  1. (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.
  2. (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.