---
kind: "section"
citation: "21 C.F.R. § 872.3930"
title: "21"
number: "872.3930"
heading: "Bone grafting material."
url: "https://uscodex.org/cfr/21/872.3930"
---

# §872.3930. Bone grafting material.

- (a) **Identification.** Bone grafting material is a material such as hydroxyapatite, tricalcium phosphate, polylactic and polyglycolic acids, or collagen, that is intended to fill, augment, or reconstruct periodontal or bony defects of the oral and maxillofacial region.
- (b) **Classification.**
  - (1) Class II (special controls) for bone grafting materials that do not contain a drug that is a therapeutic biologic. The special control is FDA's “Class II Special Controls Guidance Document: Dental Bone Grafting Material Devices.” (See [§ 872.1(e)](/cfr/21/872.1.md?p=e) for the availability of this guidance document.)
  - (2) Class III (premarket approval) for bone grafting materials that contain a drug that is a therapeutic biologic. Bone grafting materials that contain a drug that is a therapeutic biologic, such as biological response modifiers, require premarket approval.
- (c) **Date premarket approval application (PMA) or notice of product development protocol (PDP) is required.** Devices described in [paragraph (b)(2)](#b-2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.

## Notes

### Amendments

[70 FR 21949, Apr. 28, 2005]

### 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

[70 FR 21949, Apr. 28, 2005]