Data / Medical devices / File, Pulp Canal, Endodontic / United States
FDA-registered makers of File, Pulp Canal, Endodontic in the United States: 12 establishments
12 establishments in the United States are registered with the FDA to make File, Pulp Canal, Endodontic (product code EKS). 0 have a 510(k) clearance or PMA approval on file and 1 has a recall event. FDA data exported November 2, 2026.
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- Device
- File, Pulp Canal, Endodontic
- Product code
- EKS
- Country
- United States
Makers of File, Pulp Canal, Endodontic in the United States
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Brasseler U.S.A. Dental, LLC | Savannah, GA, United States | Repackager or relabeler, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Coltene/Whaledent Inc. | Cuyahoga Falls, OH, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Creative Endodontic Technology LLC | Ormond Beach, FL, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Integra LifeSciences Production Corporation | Mansfield, MA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jordco, Inc. | Hillsboro, OR, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Kerr Corporation | Pomona, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Life Science Outsourcing, Inc. | Brea, CA, United States | Contract manufacturer, Contract sterilizer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Pulpdent Corporation | Watertown, MA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| SKY DENT Corp for dental trading | New York, NY, United States | Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| SS White Burs LLC | Lakewood, NJ, United States | Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Tulsa Dental Products LLC | Johnson City, TN, United States | Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| US Endodontics, LLC | Johnson City, TN, United States | Contract manufacturer, Manufacturer, Repackager or relabeler | 0 | 0 | 1 | 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.