Data / Medical devices / Resin, Root Canal Filling
Resin, Root Canal Filling (KIF): 44 FDA-registered makers in 13 countries
44 establishments in 13 countries are registered with the FDA to make Resin, Root Canal Filling (product code KIF, Class 2, 21 CFR 872.3820). 40 of them have a 510(k) clearance or PMA approval on file and 1 has a recall event. The FDA has issued 148 510(k) clearances under this code, the latest on October 16, 2026, and lists 2 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- KIF
- Device class
- 2
- Regulation
- 872.3820
- Medical specialty
- Dental
Makers by country
| Country | Makers |
|---|---|
| United States | 15 |
| South Korea | 8 |
| Germany | 5 |
| China | 3 |
| India | 3 |
| France | 2 |
| Switzerland | 2 |
| Brazil | 1 |
| Canada | 1 |
| Italy | 1 |
| Israel | 1 |
| Japan | 1 |
| Mexico | 1 |
Makers of Resin, Root Canal Filling
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 |
|---|---|---|---|---|---|---|---|---|
| Angelus Industria De Productos Odontologicos | LONDRINA Parana, Brazil | Manufacturer | 9 | February 11, 2021 | 0 | 0 | 0 | api.fda.gov |
| Meta Biomed Co., Ltd. | Cheongju-si Chungbuk, South Korea | Manufacturer | 8 | September 29, 2023 | 0 | 0 | 0 | api.fda.gov |
| 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 |
| Diadent Group International | CHONGJU CITY Chungbuk, South Korea | Manufacturer | 5 | March 25, 2021 | 0 | 0 | 0 | api.fda.gov |
| Innovative BioCeramix, Inc | Burnaby British Columbia, Canada | Manufacturer | 5 | September 18, 2014 | 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 |
| Maruchi | Wonju-si Gangwon, South Korea | Manufacturer | 4 | February 14, 2023 | 0 | 0 | 0 | api.fda.gov |
| Mediclus Co., Ltd | Cheongju-si Chungbuk, South Korea | Manufacturer | 4 | January 12, 2026 | 0 | 0 | 0 | api.fda.gov |
| Septodont | CEDEX Val-de-Marne, France | Manufacturer | 4 | September 16, 2021 | 0 | 0 | 0 | api.fda.gov |
| Vericom Co., Ltd. | Chuncheon-Si Gangwon, South Korea | Manufacturer | 4 | September 19, 2025 | 0 | 0 | 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 |
| Gebr. Brasseler GMBH & Co. KG | LEMGO North Rhine-Westphalia, Germany | Exporter to the US, Specification developer | 3 | January 11, 2019 | 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 |
| Kerr Italia, S.r.l. | SCAFATI Salerno, Italy | Manufacturer | 3 | July 27, 2016 | 0 | 0 | 0 | api.fda.gov |
| Beijing C-Root Dental Medical Devices Co., Ltd. | Beijing, China | Manufacturer | 2 | May 10, 2024 | 0 | 0 | 0 | api.fda.gov |
| BioMTA | Daejeon, South Korea | Manufacturer | 2 | April 10, 2014 | 0 | 0 | 0 | api.fda.gov |
| Coltene/Whaledent GMBH & Co. KG | LANGENAU Baden-Wurttemberg, Germany | Exporter to the US, Manufacturer | 2 | January 26, 2024 | 0 | 0 | 0 | api.fda.gov |
| DENTSPLY DETREY GmbH | KONSTANZ Baden-Wurttemberg, Germany | Manufacturer | 2 | February 13, 2025 | 0 | 0 | 0 | api.fda.gov |
| Enpuno Biotechnology Co., Ltd | Changsha Hunan, China | Manufacturer | 2 | September 25, 2025 | 0 | 0 | 0 | api.fda.gov |
| Guilin Kevin Peter Technology Co., Ltd. | Guilin Guangxi, China | Manufacturer | 2 | August 25, 2026 | 0 | 0 | 0 | api.fda.gov |
| Pulpdent Corporation | Watertown, MA, United States | Manufacturer | 2 | October 7, 2002 | 0 | 0 | 0 | api.fda.gov |
| S & C Polymer GMBH | ELMSHORN Schleswig-Holstein, Germany | Contract manufacturer, Manufacturer | 2 | July 24, 2013 | 0 | 0 | 0 | api.fda.gov |
| Spident Co., Ltd. | INCHEON Gyeonggi, South Korea | Manufacturer | 2 | September 11, 2026 | 0 | 0 | 0 | api.fda.gov |
| Aadi Med Private Limited | Dist. Palghar Maharashtra, India | Manufacturer | 1 | July 30, 2024 | 0 | 0 | 0 | api.fda.gov |
| B.J.M. Laboratories Ltd | OR-YEHUDA Central, Israel | Manufacturer | 1 | July 31, 2017 | 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 |
| GENOSS Co., Ltd. | Suwon-si Gyeonggi, South Korea | Manufacturer | 1 | July 28, 2023 | 0 | 0 | 0 | api.fda.gov |
| Itena Clinical Villepinte | Villepinte Seine-Saint-Denis, France | Foreign private label distributor, Specification developer | 1 | July 31, 2017 | 0 | 0 | 0 | api.fda.gov |
| Kerr Corporation | Pomona, CA, United States | Manufacturer | 1 | January 7, 2026 | 0 | 0 | 0 | api.fda.gov |
| Neo Dental Chemical Products Co., Ltd. | Nagano, Japan | Manufacturer | 1 | November 6, 1997 | 0 | 0 | 0 | api.fda.gov |
| Odne AG | Dubendorf Zurich, Switzerland | Complaint file establishment, Specification developer | 1 | July 10, 2023 | 0 | 0 | 0 | api.fda.gov |
| Parkell, Inc. | Edgewood, NY, United States | Manufacturer | 1 | June 15, 2006 | 0 | 0 | 0 | api.fda.gov |
| Prevest Denpro Limited | Jammu Jammu and Kashmir, India | Manufacturer | 1 | May 23, 2022 | 0 | 0 | 0 | api.fda.gov |
| Septodont Healthcare India Private Ltd. | VILLAGE-NAVADE, TALUKA-PANVEL Maharashtra, India | Manufacturer | 1 | February 13, 2018 | 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 |
| Voco GMBH | CUXHAVEN Lower Saxony, Germany | Manufacturer | 1 | July 3, 2025 | 0 | 0 | 0 | api.fda.gov |
| GC America Inc. | Alsip, IL, United States | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Produits Dentaires SA | VEVEY (SUISSE) Vaud, Switzerland | Contract manufacturer, Foreign private label distributor | 0 | 0 | 0 | 0 | api.fda.gov | |
| SDS de Mexico S. de R.L. de C.V. | MEXICALI, B.C. C.P. Baja California, Mexico | 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 October 16, 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.