Prosthetic devices · 21 CFR 872 Subpart D
Dental Bone Grafting Material with Biologic Component
Dental bone grafting material with growth factors is a combination product which consists of a bone grafting material which contains biologic or drug components, such as proteins, that are intended to stimulate and/or inhibit the growth of certain tissues of the oral and maxillofacial region.
- Companies listing it
- 54 makers
- Brands and models
- 5
- 510(k) clearances
- 00 in five years
- FDA name
- Bone Grafting Material, Dental, With Biologic Component
Companies that list NPZ
5 companies currently list this device type with FDA.
| Company | Country | Role | Brands and models listed | Clearances | Latest |
|---|---|---|---|---|---|
| Medtronic, Inc. | United States | Maker | INFUSE BONGRAFT for Oral Max | 11 | 2014 |
| A+ Secure Packaging | United States | Maker | Gem 21S | — | — |
| Altasciences CDMO Philadelphia, LLC | United States | Maker | GEM 21S® Growth-Factor Enhanced Matrix | — | — |
| Lynch Biologics LLC | United States | Maker | Gem 21S | — | — |
| Sotera Health LLC | United States | Contract manufacturer | Pepgen P-15 | — | — |
Official records: FDA product classification for NPZ · 21 CFR 872.3930.
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026