Regulatory Text
21 C.F.R. § 872.3580 — Preformed gold denture tooth.
§ 872.3580 Preformed gold denture tooth. (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. [52 FR 30097, Aug. 12, 1987, as amended at 59 FR 63008, Dec. 7, 1994; 66 FR 38798, July 25, 2001]
Source: ecfr.gov · govinfo.gov — public domain
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Root-LD v1.0 · boisestandard.org
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BS-CFR21-SEC-07331E
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Citation
21 C.F.R. § 872.3580
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The regulatory text of 21 C.F.R. § 872.3580 is reproduced from the official Code of Federal Regulations as published by the Office of the Federal Register and the National Archives and Records Administration.
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21 C.F.R. — public domain
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