21 CFR 872.3850
§ 872.3850 Gutta percha.
United States · 21 CFR — Food and Drugs · Status: effective
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- Citation
- 21 CFR 872.3850, § 872.3850 Gutta percha, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/90115
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Full text
(a) Identification. Gutta percha is a device made from coagulated sap of certain tropical trees intended to fill the root canal of a tooth. The gutta percha is softened by heat and inserted into the root canal, where it hardens as it cools.
(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.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.