Data / Medical devices / Liner, Cavity, Calcium Hydroxide / United States
FDA-registered makers of Liner, Cavity, Calcium Hydroxide in the United States: 14 establishments
14 establishments in the United States are registered with the FDA to make Liner, Cavity, Calcium Hydroxide (product code EJK). 11 have a 510(k) clearance or PMA approval on file and 0 have a recall event. FDA data exported November 2, 2026.
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- Device
- Liner, Cavity, Calcium Hydroxide
- Product code
- EJK
- Country
- United States
Makers of Liner, Cavity, Calcium Hydroxide in the United States
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Pulpdent Corporation | Watertown, MA, United States | Manufacturer, Repackager or relabeler | 3 | April 5, 2012 | 0 | 0 | 0 | api.fda.gov |
| Bisco, Inc. | Schaumburg, IL, United States | Manufacturer | 2 | April 5, 2018 | 0 | 0 | 0 | api.fda.gov |
| Dentsply LLC | Milford, DE, United States | Manufacturer | 2 | July 23, 1992 | 0 | 0 | 0 | api.fda.gov |
| Solventum US LLC | Irvine, CA, United States | Manufacturer, Repackager or relabeler | 2 | February 6, 2023 | 0 | 0 | 0 | api.fda.gov |
| Kerr Corporation | Orange, CA, United States | Complaint file establishment, Specification developer | 1 | October 25, 2001 | 0 | 0 | 0 | api.fda.gov |
| Nusmile, Ltd | Houston, TX, United States | Manufacturer, Repackager or relabeler, Specification developer | 1 | November 20, 2020 | 0 | 0 | 0 | api.fda.gov |
| Parkell, Inc. | Edgewood, NY, United States | Manufacturer | 1 | November 22, 2019 | 0 | 0 | 0 | api.fda.gov |
| Solventum Us LLC | Eagan, MN, United States | Complaint file establishment, Manufacturer, Specification developer | 1 | February 6, 2023 | 0 | 0 | 0 | api.fda.gov |
| Solventum US LLC | San Antonio, TX, United States | Complaint file establishment, Manufacturer, Specification developer | 1 | February 6, 2023 | 0 | 0 | 0 | api.fda.gov |
| Temrex Corp. | Freeport, NY, United States | Manufacturer | 1 | March 27, 1990 | 0 | 0 | 0 | api.fda.gov |
| Ultradent Products Inc. | South Jordan, UT, United States | Manufacturer | 1 | April 2, 1997 | 0 | 0 | 0 | api.fda.gov |
| George Taub Products & Fusion Co., Inc. | Jersey City, NJ, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Scientific Pharmaceuticals, Inc. | Pomona, CA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Viarden Lab LLC | Mission, TX, United States | Manufacturer for export | 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.