Data / Medical devices / Resin, Root Canal Filling / United States
FDA-registered makers of Resin, Root Canal Filling in the United States: 15 establishments
15 establishments in the United States are registered with the FDA to make Resin, Root Canal Filling (product code KIF). 13 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
- Resin, Root Canal Filling
- Product code
- KIF
- Country
- United States
Makers of Resin, Root Canal Filling in the United States
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Tulsa Dental Products LLC | Johnson City, TN, United States | Manufacturer, Repackager or relabeler, Specification developer | 7 | February 26, 2018 | 0 | 0 | 0 | api.fda.gov |
| Nusmile, Ltd | Houston, TX, United States | Manufacturer | 5 | September 4, 2026 | 0 | 0 | 0 | api.fda.gov |
| Ultradent Products Inc. | South Jordan, UT, United States | Manufacturer, Repackager or relabeler | 5 | October 13, 2021 | 0 | 0 | 0 | api.fda.gov |
| Kerr Corporation | Orange, CA, United States | Complaint file establishment, Specification developer | 4 | June 7, 2019 | 0 | 1 | 0 | api.fda.gov |
| Essential Dental Systems, Inc. | S Hackensack, NJ, United States | Repackager or relabeler, Specification developer | 3 | February 12, 2021 | 0 | 0 | 0 | api.fda.gov |
| Inter-Med, Inc. | Racine, WI, United States | Manufacturer, Repackager or relabeler | 3 | August 28, 2024 | 0 | 0 | 0 | api.fda.gov |
| Pulpdent Corporation | Watertown, MA, United States | Manufacturer | 2 | October 7, 2002 | 0 | 0 | 0 | api.fda.gov |
| Coltene/Whaledent Inc. | Cuyahoga Falls, OH, United States | Manufacturer | 1 | January 10, 1990 | 0 | 0 | 0 | api.fda.gov |
| Dental Technologies, Inc. | Lincolnwood, IL, United States | Manufacturer | 1 | December 6, 1996 | 0 | 0 | 0 | api.fda.gov |
| Kerr Corporation | Pomona, CA, United States | Manufacturer | 1 | January 7, 2026 | 0 | 0 | 0 | api.fda.gov |
| Parkell, Inc. | Edgewood, NY, United States | Manufacturer | 1 | June 15, 2006 | 0 | 0 | 0 | api.fda.gov |
| Sprig Oral Health Technologies, Inc. | Rocklin, CA, United States | Specification developer | 1 | March 24, 2023 | 0 | 0 | 0 | api.fda.gov |
| Temrex Corp. | Freeport, NY, United States | Specification developer | 1 | March 9, 1992 | 0 | 0 | 0 | api.fda.gov |
| GC America Inc. | Alsip, IL, United States | Complaint file establishment, 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.