Data / Medical devices / Barrier, Animal Source, Intraoral / United States
FDA-registered makers of Barrier, Animal Source, Intraoral in the United States: 12 establishments
12 establishments in the United States are registered with the FDA to make Barrier, Animal Source, Intraoral (product code NPL). 7 have a 510(k) clearance or PMA approval on file and 3 have a recall event. FDA data exported November 2, 2026.
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- Device
- Barrier, Animal Source, Intraoral
- Product code
- NPL
- Country
- United States
Makers of Barrier, Animal Source, Intraoral in the United States
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Collagen Matrix, Inc. | Oakland, NJ, United States | Manufacturer, Specification developer | 11 | May 1, 2024 | 0 | 1 | 0 | api.fda.gov |
| Collagen Matrix, Inc | Allendale, NJ, United States | Manufacturer | 6 | May 1, 2024 | 0 | 1 | 0 | api.fda.gov |
| DSM Biomedical, Inc. | Exton, PA, United States | Manufacturer | 3 | June 7, 2016 | 0 | 1 | 0 | api.fda.gov |
| Cook Biotech, Inc. | West Lafayette, IN, United States | Manufacturer | 2 | January 13, 2017 | 0 | 0 | 0 | api.fda.gov |
| Osteogenics Biomedical, Inc. | Lubbock, TX, United States | Contract manufacturer, Repackager or relabeler | 1 | August 7, 2001 | 0 | 0 | 0 | api.fda.gov |
| RTI Surgical, Inc. (dba RTI Biologics, Inc.) | Alachua, FL, United States | Specification developer | 1 | May 12, 2008 | 0 | 0 | 0 | api.fda.gov |
| Sigmagraft, Inc. | Fullerton, CA, United States | Manufacturer | 1 | August 17, 2023 | 0 | 0 | 0 | api.fda.gov |
| Armm, Inc. | Huntington Beach, CA, United States | Contract manufacturer, Contract sterilizer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Isomedix Operations Inc. | Spartanburg, SC, United States | Contract sterilizer, Manufacturer for export | 0 | 0 | 0 | 0 | api.fda.gov | |
| Lifecell Corp | Branchburg, NJ, United States | Manufacturer for export | 0 | 0 | 0 | 0 | api.fda.gov | |
| Lifecell Corp. | Branchburg, NJ, United States | Manufacturer for export | 0 | 0 | 0 | 0 | api.fda.gov | |
| Millstone Medical Outsourcing LLC | Olive Branch, MS, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated November 2, 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.