CFR > Title 21 - Food and Drugs > CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES > SUBCHAPTER H—MEDICAL DEVICES (parts 800 to 898) > PART 872—DENTAL DEVICES > SUBPART D—Prosthetic Devices (§872.3060 to §872.3980) > 872.3850—Gutta percha.

872.3850—Gutta percha.

(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.

Code of Federal Regulations

[52 FR 30097, Aug. 12, 1987, as amended at 54 FR 13830, Apr. 5, 1989; 66 FR 38798, July 25, 2001]