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) → NPZ — Bone Grafting Material, Dental, With Biologic Component

# NPZ · Bone Grafting Material, Dental, With Biologic Component

_Dental · 21 CFR 872.3930 · Class 3_

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

## Overview

- **Product Code:** NPZ
- **Device Name:** Bone Grafting Material, Dental, With Biologic Component
- **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 (3 of 3)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [P050053](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/NPZ/P050053.md) | INFUSE BONE GRAFT | Medtronic, Inc. | Mar 9, 2007 | APPR |
| [P040013](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/NPZ/P040013.md) | GEM 21S (GROWTH-FACTOR ENHANCED MATRIX | Lynch Biologics, LLC | Nov 18, 2005 | APPR |
| [P990033](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/NPZ/P990033.md) | PEPGEN P-15 | Ceramed Corp. | Oct 25, 1999 | APWD |

## Top Applicants

- Medtronic, Inc. — 1 clearance
- Lynch Biologics, LLC — 1 clearance
- Ceramed Corp. — 1 clearance

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

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