Current through November 30, 2024
Section 872.3130 - Preformed anchor(a)Identification. A preformed anchor is a device made of austenitic alloys or alloys containing 75 percent or greater gold or metals of the platinum group intended to be incorporated into a dental appliance, such as a denture, to help stabilize the appliance in the patient's mouth.(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 .52 FR 30097, Aug. 12, 1987, as amended at 59 FR 63008, Dec. 7, 1994; 66 FR 38797 , July 25, 2001