§ 872.3850. Gutta percha.
95 words·~1 min read·
/us/cfr/t21/s§ 872.3850·A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
(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. [52 FR 30097, Aug. 12, 1987, as amended at 54 FR 13830, Apr. 5, 1989; 66 FR 38798, July 25, 2001]