21 C.F.R. § 872.3850 Gutta percha.
Title 21 - Food and Drugs
(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]
Title 21: Food and Drugs
PART 872—DENTAL DEVICES
Subpart D—Prosthetic Devices
§ 872.3850 Gutta percha.
