21 CFR 872.6200
§ 872.6200 Base plate shellac.
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 872.6200, § 872.6200 Base plate shellac, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/90164
- Permanent ID
ys:prov:90164@1- SHA-256
7ba0fe99d3d3353c332edb33ce808b305c37400095e55916af5ff2f3838abbd2
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Full text
(a) Identification. Base plant shellac is a device composed of shellac intended to rebuild the occlusal rim of full or partial dentures.
(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. If the device is not labeled or otherwise represented as sterile, it is exempt from the current good manufacturing practice requirements of the quality management system regulation in part 820 of this chapter, except for requirements concerning records and complaint files under § 820.35 of this chapter.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.