Browse hierarchy: [Dental (DE)](/submissions/DE) → [Subpart D — Prosthetic Devices](/submissions/DE/subpart-d%E2%80%94prosthetic-devices) → [21 CFR 872.3930](/submissions/DE/subpart-d%E2%80%94prosthetic-devices/872.3930) → NQA — Biologic Material, Dental

# NQA · Biologic Material, Dental

_Dental · 21 CFR 872.3930 · Class 3_

**Canonical URL:** https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/NQA

## Overview

- **Product Code:** NQA
- **Device Name:** Biologic Material, Dental
- **Regulation:** [21 CFR 872.3930](/submissions/DE/subpart-d%E2%80%94prosthetic-devices/872.3930)
- **Device Class:** 3
- **Review Panel:** [Dental](/submissions/DE)
- **Implant:** yes

## 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.

## Classification Rationale

(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) 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.

## Special Controls

*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) 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) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.

## Recent Cleared Devices (1 of 1)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [P930021](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/NQA/P930021.md) | BIORA EMDOGAIN(R) | The Straumann Company | Sep 30, 1996 | APPR |

## Top Applicants

- The Straumann Company — 1 clearance

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**Source:** [https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/NQA](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/NQA)

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