Data / Medical devices / Barrier, Synthetic, Intraoral
Barrier, Synthetic, Intraoral (NPK): 12 FDA-registered makers in 6 countries
12 establishments in 6 countries are registered with the FDA to make Barrier, Synthetic, Intraoral (product code NPK, Class 2, 21 CFR 872.3930). 10 of them have a 510(k) clearance or PMA approval on file and 1 has a recall event. The FDA has issued 31 510(k) clearances under this code, the latest on December 8, 2023, and lists 1 recall event (0 Class I). FDA data exported November 2, 2026.
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- Product code
- NPK
- Device class
- 2
- Regulation
- 872.3930
- Medical specialty
- Dental
- Implant
- Yes
Makers by country
| Country | Makers |
|---|---|
| United States | 6 |
| South Korea | 2 |
| Finland | 1 |
| Switzerland | 1 |
| Sweden | 1 |
| United Kingdom | 1 |
Makers of Barrier, Synthetic, Intraoral
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| 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 |
| Cowellmedi Co., Ltd. | Busan, South Korea | Manufacturer | 1 | February 24, 2023 | 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 |
| Inion OY | TAMPERE Pirkanmaa, Finland | Manufacturer | 1 | March 31, 2004 | 0 | 1 | 0 | api.fda.gov |
| Institut Straumann AG | BASEL Basel-Stadt, Switzerland | Specification developer | 1 | May 22, 2009 | 0 | 0 | 0 | api.fda.gov |
| Neoss AB | Goteborg Vastra Gotaland, Sweden | Manufacturer | 1 | April 13, 2015 | 0 | 0 | 0 | api.fda.gov |
| Purgo Biologics Inc. | Seongnam-si Gyeonggi, South Korea | Manufacturer | 1 | May 11, 2023 | 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 | |
| Wesley Coe (cambridge) Ltd | ELY, CAMBS Cambridgeshire, United Kingdom | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated December 8, 2023. 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.