Data / Medical devices / Barrier, Synthetic, Intraoral / United States
FDA-registered makers of Barrier, Synthetic, Intraoral in the United States: 6 establishments
6 establishments in the United States are registered with the FDA to make Barrier, Synthetic, Intraoral (product code NPK). 5 have a 510(k) clearance or PMA approval on file and 0 have a recall event. FDA data exported November 3, 2026.
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- Device
- Barrier, Synthetic, Intraoral
- Product code
- NPK
- Country
- United States
Makers of Barrier, Synthetic, Intraoral in the United States
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Osteogenics Biomedical, Inc. | Lubbock, TX, United States | Manufacturer | 2 | January 23, 2021 | 0 | 0 | 0 | api.fda.gov |
| Collagen Matrix, Inc. | Oakland, NJ, United States | Specification developer | 1 | October 29, 2013 | 0 | 0 | 0 | api.fda.gov |
| Collagen Matrix, Inc | Allendale, NJ, United States | Manufacturer, Manufacturer for export | 1 | October 29, 2013 | 0 | 0 | 0 | api.fda.gov |
| Salvin Dental Specialties, LLC | Charlotte, NC, United States | Specification developer | 1 | September 8, 2016 | 0 | 0 | 0 | api.fda.gov |
| Unicare Biomedical, Inc. | Laguna Hills, CA, United States | Manufacturer | 1 | November 19, 2015 | 0 | 0 | 0 | api.fda.gov |
| Life Science Outsourcing | Somersworth, NH, United States | Contract manufacturer, Contract sterilizer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated November 3, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.