Prosthetic devices · 21 CFR 872 Subpart D
Dental Biologic Material
Other dental material with growth factors is a material, used with or without other devices, 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
- Biologic Material, Dental
Companies that list NQA
5 companies currently list this device type with FDA.
| Company | Country | Role | Brands and models listed | Clearances | Latest |
|---|---|---|---|---|---|
| Institut Straumann AG | Switzerland | Maker | STRAUMANN EMDOGAIN | 212 | 2026 |
| 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 | biologic material, dental Straumann Emdogain 0.3 ml, Multipack | — | — |
Official records: FDA product classification for NQA · 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