---
kind: "section"
citation: "21 C.F.R. § 872.3820"
title: "21"
number: "872.3820"
heading: "Root canal filling resin."
url: "https://uscodex.org/cfr/21/872.3820"
---

# §872.3820. Root canal filling resin.

- (a) **Identification.** A root canal filling resin is a device composed of material, such as methylmethacrylate, intended for use during endodontic therapy to fill the root canal of a tooth.
- (b) **Classification.**
  - (1) **Class II if chloroform is not used as an ingredient in the device.**
  - (2) **Class III if chloroform is used as an ingredient in the device.**
- (c) **Date PMA or notice of completion of a PDP is required.** A PMA or a notice of completion of a PDP is required to be filed with the Food and Drug Administration on or before December 26, 1996 for any root canal filling resin described in [paragraph (b)(2)](#b-2) of this section that was in commercial distribution before May 28, 1976, or that has, on or before December 26, 1996 been found to be substantially equivalent to a root canal filling resin described in [paragraph (b)(2)](#b-2) of this section that was in commercial distribution before May 28, 1976. Any other root canal filling resin shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.

## Notes

### Amendments

[52 FR 30097, Aug. 12, 1987, as amended at 61 FR 50707, Sept. 27, 1996]

### Authority

Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360 l, 371.

### Source

Source: 52 FR 30097, Aug. 12, 1987, unless otherwise noted.

### Amendments

[52 FR 30097, Aug. 12, 1987, as amended at 61 FR 50707, Sept. 27, 1996]