Data / Medical devices / Cleanser, Root Canal / United States
FDA-registered makers of Cleanser, Root Canal in the United States: 17 establishments
17 establishments in the United States are registered with the FDA to make Cleanser, Root Canal (product code KJJ). 11 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
- Cleanser, Root Canal
- Product code
- KJJ
- Country
- United States
Makers of Cleanser, Root Canal in the United States
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Inter-Med, Inc. | Racine, WI, United States | Manufacturer | 5 | August 27, 2024 | 0 | 1 | 0 | api.fda.gov |
| Ultradent Products Inc. | South Jordan, UT, United States | Manufacturer | 4 | February 9, 2018 | 0 | 0 | 0 | api.fda.gov |
| Essential Dental Systems, Inc. | S Hackensack, NJ, United States | Repackager or relabeler, Specification developer | 3 | February 25, 2015 | 0 | 0 | 0 | api.fda.gov |
| Pac-Dent Inc. | Brea, CA, United States | Specification developer | 3 | July 25, 2016 | 0 | 0 | 0 | api.fda.gov |
| Coltene/Whaledent Inc. | Cuyahoga Falls, OH, United States | Specification developer | 2 | October 28, 2011 | 0 | 0 | 0 | api.fda.gov |
| Epien Medical, Inc. | White Bear Lake, MN, United States | Complaint file establishment, Manufacturer | 2 | September 9, 2021 | 0 | 0 | 0 | api.fda.gov |
| Kerr Corporation | Orange, CA, United States | Complaint file establishment, Specification developer | 2 | March 5, 2003 | 0 | 0 | 0 | api.fda.gov |
| Kerr Corporation | Pomona, CA, United States | Complaint file establishment, Manufacturer | 2 | March 5, 2003 | 0 | 0 | 0 | api.fda.gov |
| Tulsa Dental Products LLC | Johnson City, TN, United States | Manufacturer, Specification developer | 2 | February 14, 2011 | 0 | 0 | 0 | api.fda.gov |
| Jordco, Inc. | Hillsboro, OR, United States | Manufacturer | 1 | October 14, 1999 | 0 | 0 | 0 | api.fda.gov |
| Sonoma Pharmaceuticals, Inc. | Boulder, CO, United States | Manufacturer | 1 | August 18, 2014 | 0 | 0 | 0 | api.fda.gov |
| Dental Technologies, Inc. | Lincolnwood, IL, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Dentsply LLC | Milford, DE, United States | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Kerr Corporation | Pomona, CA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Premier Dental Products Co. | Plymouth Meeting, PA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Silgan Unicep Packaging, LLC. | Sandpoint, ID, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Young Dental Manufacturing Co 1, LLC. | Earth City, MO, 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.