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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

CountryMakers
United States15
South Korea8
Germany5
China3
India3
France2
Switzerland2
Brazil1
Canada1
Italy1
Israel1
Japan1
Mexico1

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.

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Angelus Industria De Productos OdontologicosLONDRINA Parana, BrazilManufacturer9February 11, 2021000api.fda.gov
Meta Biomed Co., Ltd.Cheongju-si Chungbuk, South KoreaManufacturer8September 29, 2023000api.fda.gov
Tulsa Dental Products LLCJohnson City, TN, United StatesManufacturer, Repackager or relabeler, Specification developer7February 26, 2018000api.fda.gov
Diadent Group InternationalCHONGJU CITY Chungbuk, South KoreaManufacturer5March 25, 2021000api.fda.gov
Innovative BioCeramix, IncBurnaby British Columbia, CanadaManufacturer5September 18, 2014000api.fda.gov
Nusmile, LtdHouston, TX, United StatesManufacturer5September 4, 2026000api.fda.gov
Ultradent Products Inc.South Jordan, UT, United StatesManufacturer, Repackager or relabeler5October 13, 2021000api.fda.gov
Kerr CorporationOrange, CA, United StatesComplaint file establishment, Specification developer4June 7, 2019010api.fda.gov
MaruchiWonju-si Gangwon, South KoreaManufacturer4February 14, 2023000api.fda.gov
Mediclus Co., LtdCheongju-si Chungbuk, South KoreaManufacturer4January 12, 2026000api.fda.gov
SeptodontCEDEX Val-de-Marne, FranceManufacturer4September 16, 2021000api.fda.gov
Vericom Co., Ltd.Chuncheon-Si Gangwon, South KoreaManufacturer4September 19, 2025000api.fda.gov
Essential Dental Systems, Inc.S Hackensack, NJ, United StatesRepackager or relabeler, Specification developer3February 12, 2021000api.fda.gov
Gebr. Brasseler GMBH & Co. KGLEMGO North Rhine-Westphalia, GermanyExporter to the US, Specification developer3January 11, 2019000api.fda.gov
Inter-Med, Inc.Racine, WI, United StatesManufacturer, Repackager or relabeler3August 28, 2024000api.fda.gov
Kerr Italia, S.r.l.SCAFATI Salerno, ItalyManufacturer3July 27, 2016000api.fda.gov
Beijing C-Root Dental Medical Devices Co., Ltd.Beijing, ChinaManufacturer2May 10, 2024000api.fda.gov
BioMTADaejeon, South KoreaManufacturer2April 10, 2014000api.fda.gov
Coltene/Whaledent GMBH & Co. KGLANGENAU Baden-Wurttemberg, GermanyExporter to the US, Manufacturer2January 26, 2024000api.fda.gov
DENTSPLY DETREY GmbHKONSTANZ Baden-Wurttemberg, GermanyManufacturer2February 13, 2025000api.fda.gov
Enpuno Biotechnology Co., LtdChangsha Hunan, ChinaManufacturer2September 25, 2025000api.fda.gov
Guilin Kevin Peter Technology Co., Ltd.Guilin Guangxi, ChinaManufacturer2August 25, 2026000api.fda.gov
Pulpdent CorporationWatertown, MA, United StatesManufacturer2October 7, 2002000api.fda.gov
S & C Polymer GMBHELMSHORN Schleswig-Holstein, GermanyContract manufacturer, Manufacturer2July 24, 2013000api.fda.gov
Spident Co., Ltd.INCHEON Gyeonggi, South KoreaManufacturer2September 11, 2026000api.fda.gov
Aadi Med Private LimitedDist. Palghar Maharashtra, IndiaManufacturer1July 30, 2024000api.fda.gov
B.J.M. Laboratories LtdOR-YEHUDA Central, IsraelManufacturer1July 31, 2017000api.fda.gov
Coltene/Whaledent Inc.Cuyahoga Falls, OH, United StatesManufacturer1January 10, 1990000api.fda.gov
Dental Technologies, Inc.Lincolnwood, IL, United StatesManufacturer1December 6, 1996000api.fda.gov
GENOSS Co., Ltd.Suwon-si Gyeonggi, South KoreaManufacturer1July 28, 2023000api.fda.gov
Itena Clinical VillepinteVillepinte Seine-Saint-Denis, FranceForeign private label distributor, Specification developer1July 31, 2017000api.fda.gov
Kerr CorporationPomona, CA, United StatesManufacturer1January 7, 2026000api.fda.gov
Neo Dental Chemical Products Co., Ltd.Nagano, JapanManufacturer1November 6, 1997000api.fda.gov
Odne AGDubendorf Zurich, SwitzerlandComplaint file establishment, Specification developer1July 10, 2023000api.fda.gov
Parkell, Inc.Edgewood, NY, United StatesManufacturer1June 15, 2006000api.fda.gov
Prevest Denpro LimitedJammu Jammu and Kashmir, IndiaManufacturer1May 23, 2022000api.fda.gov
Septodont Healthcare India Private Ltd.VILLAGE-NAVADE, TALUKA-PANVEL Maharashtra, IndiaManufacturer1February 13, 2018000api.fda.gov
Sprig Oral Health Technologies, Inc.Rocklin, CA, United StatesSpecification developer1March 24, 2023000api.fda.gov
Temrex Corp.Freeport, NY, United StatesSpecification developer1March 9, 1992000api.fda.gov
Voco GMBHCUXHAVEN Lower Saxony, GermanyManufacturer1July 3, 2025000api.fda.gov
GC America Inc.Alsip, IL, United StatesComplaint file establishment, Manufacturer0000api.fda.gov
Produits Dentaires SAVEVEY (SUISSE) Vaud, SwitzerlandContract manufacturer, Foreign private label distributor0000api.fda.gov
SDS de Mexico S. de R.L. de C.V.MEXICALI, B.C. C.P. Baja California, MexicoContract manufacturer0000api.fda.gov
Viarden Lab LLCMission, TX, United StatesManufacturer for export0000api.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.