Endodontic files: manufacturers and brands
137 companies make or specify endodontic files among the 182 that list one with FDA, under 2,102 brand and model names. FDA has issued 46 510(k) clearances in this category, 0 of them in the last five years.
510(k) clearances per year, 1976–2026
Endodontic file manufacturers
Makers first, then the most recently active. “Maker” means the company manufactures the device or owns its specifications; a “lister” repacks, relabels, imports or distributes it.
| Company | Country | Role | Brands and models listed | Clearances | Latest |
|---|---|---|---|---|---|
| Dentsply Sirona, Inc. | United States | Maker | — | 148 | 2026 |
| Mediclus Co., Ltd | South Korea | Maker | Endo@Prep EDTA Cream · Endo@Prep EDTA Gel · MD-Solution | 15 | 2026 |
| Spident Co., Ltd. | South Korea | Maker | SoftPrep | 22 | 2026 |
| Voco GmbH | Germany | Maker | Reamer | 117 | 2026 |
| DiaDent Group International | South Korea | Maker | DiaPrep Pro · DIA-X FILE · H-FILE (NICKEL-TITANIUM) · Hedstrom Files · +5 | 24 | 2026 |
| Sybron Dental Specialties | United States | Maker | Pulp Canal · Reamers · Barbed Broach · Hedstrom Files · +23 | 203 | 2026 |
| Prevest Denpro Limited | India | Maker | Rotoflex Blue files · Rotoflex Gold files | 7 | 2024 |
| Foshan COXO Medical Instrument Co., Ltd. | China | Maker | Dental Root Canal Instruments;C-File Flow L,C-File Mini,C-File Re,C-File Blue,C-File One Super · Dental Root Canal Instruments;C-File,C-File Pro,C-File Pilot,C-File Gold,C-File One Plus,C-File One Pro,C-File Plus · F1VK-21,F1VK-25,F1VK-31 · F2VK-21,F2VK-25,F2VK-31 · +69 | 6 | 2025 |
| Inter-Med, Inc. | United States | Maker | Citric Acid · EndoUltra Tip Kit 15/02 · Rinse-N-Dry · Versa Brush · +11 | 7 | 2026 |
| Meta Biomed Co, Ltd | United States | Maker | Aurum · GL153 · MD-ChelCream · MD-Cleanser | 24 | 2024 |
| Premier Dental Products Company | United States | Maker | RC PREP | 28 | 2026 |
| Changzhou Sifary Medical Technology Co., Ltd. | China | Maker | E-FLEX, E-FLEX S, E-FLEX BLUE, E-FLEX GOLD, E-FLEX EDGE, E-FLEX RT, E-FLEX REC, E-FLEX ONE, E-FLEX MINI · E-STYLE GOLD, E-STYLE BLUE, E-Aurora | 4 | 2026 |
| Guilin Kevin Peter Technology Co., Ltd. | China | Maker | EDTA Root Canal Lubricating Gel · EDTA Solution · Disposable Sterile Root Canal File · Root Canal File · +1 | 3 | 2026 |
| Vericom Co., Ltd. | South Korea | Maker | WELL-PREP ROOT CANAL CLEANSER | 20 | 2026 |
| Hager& Meisinger GmbH | Germany | Maker | MEISINGER | 14 | 2025 |
| Pac-Dent Inc. | United States | Maker | JS Dental | 5 | 2022 |
| Imicryl Dis Malzemeleri Sanayi VE Ticaret AS | Türkiye | Maker | Prosimi, E.D.T.A Solution, Endosolve-HP | 5 | 2022 |
| HDI Inc. | South Korea | Maker | Denu EDTA Cream | 2 | 2022 |
| Beijing C-Root Dental Medical Devices Co., LTD. | China | Maker | C-Root EDTA Gel · C-Root EDTA Solution · EDTA root canal lubrication gel · C-Root File | 2 | 2024 |
| Coltene/Whaledent AG | Switzerland | Maker | CanalPro EDTA · MM-EDTA CREAM · H-Files · HEDSTROEM FILES · +34 | 45 | 2022 |
| Essential Dental Systems, Inc. | United States | Maker | Safesider HF · SafeSiders | 15 | 2023 |
| Maruchi | South Korea | Maker | EndoRoad · EndoRoad N · EndoRoad P · EndoRoad S · +8 | 8 | 2023 |
| Foshan Cicada Dental Instrument Co, Ltd. | China | Maker | Endo Files, Dental Engine Files, Endo Hand Files | 4 | 2022 |
| ChangZhou BoMedent Medical Technology Co., Ltd | China | Maker | SCM-019, iBon, iBon Mini, iBon Mini-SE | 2 | 2022 |
| Ze Fang Technology Co., Ltd. | Taiwan | Maker | Root Canal Files M1-C Single #10 19mm · Root Canal Files M1-C Single #10 21mm · Root Canal Files M1-C Single #10 25mm · Root Canal Files M1-C Single #10 31mm · +283 | 1 | 2022 |
| Shenzhen Rogin Medical Co., Ltd. | China | Maker | DK-Files, Fire-Files, Pro-path Files, Sup-path Files, · Endo Training Kit, Niti Spreader, Niti Plugger · EZ Shaper, EZ Shaper PRO, UNI-SHAPE Files, SF-SHAPE FILES, · Files holder, C+ Files, U Files, Microscope Files · +42 | 1 | 2025 |
| DentalMaster (Xiamen) Medical Technology Co., Ltd. | China | Maker | PTFE Tape Removal Instrument | 1 | 2026 |
| Shenzhen Superline Technology Co Ltd | China | Maker | Deltajet · Fliex · NIC · ROOT.X · +2 | 1 | 2025 |
| Foshan SOCO Precision Instrument Co.,Ltd. | China | Maker | Dental Root Canal Instrument · SC,SC-PRO,SC plus,S-one plus,S-one pro,SX-F3,SC-GOLD · SX,S1,S2,F1,F2,F3 · 1002,1202,1302,1502,1602,1902,2002,2502,3002,3502,4002 · +4 | 1 | 2024 |
| Denjoy Dental Co., Ltd. | China | Maker | Rotary File,K-File,H-File,K-Reamer | 1 | 2025 |
| Shenzhen Perfect Medical Instruments Co., Ltd. | China | Maker | FILE, PULP CANAL, ENDODONTIC; profa file | 1 | 2023 |
| Pulpdent Corporation | United States | Maker | Root Canal Discs · Root Canal Spreader Dryer · EDTA · 17% SOLUTION | 107 | 2021 |
| Angelus Industria DE Produtos Odontologicos S/A | Brazil | Maker | Nexis Endodontic Files | 11 | 2021 |
| Prime Dental Manufacturing, Inc. | United States | Maker | Prime-Dent Root Canal Filling Material · RC-CREAM | 9 | 2012 |
| Micron Corporation | Japan | Maker | M-Tip | 5 | 2018 |
| GNI Co., LTD | South Korea | Maker | Endo | 3 | 2021 |
| Integra LifeSciences Corporation | United States | Maker | Integra · Miltex · Flex-R · Hi-5 · +3 | 2 | 2014 |
| Medical Products Laboratories, Inc. | United States | Maker | — | 2 | 2004 |
| B&L Biotech Co., Ltd. | South Korea | Maker | B&L Paper Point · CI120-A · CI120-E · CI90-A · +98 | 1 | 2006 |
| Directa AB | Sweden | Maker | K-reamer · H-file · K-file · S-file · +2 | 1 | 2015 |
| COLTENE Holding AG | Switzerland | Maker | HyFlex CM, HyFlex EDM | 1 | 2003 |
| Gebr. Brasseler GmbH & Co. KG | Germany | Maker | KOMET ENDODONTIC ROOT CANAL REAMER · KOMET ENDODONTIC ROOT CANAL FILE, K-FILE, HEDSTROEM FILE | 1 | 2007 |
| Abrasive Technology, Inc. | United States | Maker | — | 1 | 1990 |
| SS White Burs LLC | United States | Maker | File, Pulp, Endodontic - DCTAPER, DCTAPERH, EXACTFLOW, EXACTFLOWH, EXACTTAPER, EXACTTAPERH, EXACTGUIDE, EXACTTAPERH DC · File, Pulp, Endodontic - DCTAPER, DCTAPERH, EXACTFLOWH, EXACTTAPER, EXACTTAPERH | 1 | 2008 |
| BioMTA | South Korea | Maker | OrhtoMTA Compactor | 1 | 2014 |
| Endoperfection Ltd | United Kingdom | Maker | Gates Gliddens, 1-6, 28 · Gates Gliddens, 1-6, 32 · Gates Gliddens, 1, 28 · Gates Gliddens, 1, 32 · +565 | — | — |
| Guilin Yikeshi Medical Instrument Co Ltd | China | Maker | xp-37 · xp-39 · xp-E10D · xp-E11 · +41 | — | — |
| Dentaurum GmbH & Co. KG | Germany | Maker | Reamer | — | — |
| Debo Medical Technology (Shijiazhuang) Co., Ltd. | China | Maker | dental pulp · dental pulp cavity · Endo File · endodontic root canal file · +2 | — | — |
| B. Ali Impex | Pakistan | Maker | BALI · DOCTOR NICE | — | — |
| Shenzhen Denco Medical Co Ltd | China | Maker | C Plus files; PD files; Microscope File Holder; Smart files holder · D Files · DK Files · DR Files · +42 | — | — |
| 3R Industria e Comercio Ltda | Brazil | Maker | ForceFlex Rotary File 7 4 #17 21MM, C/6 · ForceFlex Rotary File 7 4 #17 25MM, C/6 · ForceFlex Rotary File 7 4 #17 29MM, C/6 · ForceFlex Rotary File 7 4 #20 21MM, C/6 · +77 | — | — |
| Aspen Surgical Products | United States | Maker | Symmetry Surgical | — | — |
| Falcon Surgical Co. (Pvt.) Ltd. | Pakistan | Maker | REAMER, PULP CANAL, ENDODONTIC | — | — |
| Pomee Corporation | Pakistan | Maker | Endodontic Explorers · Endodontic Instruments · Root Canal Spreaders · Stieglitz Fragment Forceps | — | — |
| US Endodontics, LLC | United States | Maker | Channels Flex · Channels One · Channels Performance Taper C Series · Channels Performance Taper G series · +36 | — | — |
| FKG Dentaire Sarl | Switzerland | Maker | BROACHES · EndoSequence Hand Files · FILES · FKG · +50 | — | — |
| Medcave Private Limited | Pakistan | Maker | File Endodontic | — | — |
| Shanghai Dochem Industries Co., Ltd. | China | Maker | Niti/Stainless Steel Endo File | — | — |
| Accompany Surgical | Pakistan | Maker | Root Canal Spreader | — | — |
| Aesculap AG | Germany | Maker | aesculap | — | — |
| Beyes Dental Inc | Canada | Maker | Curvea Endodontics Files; Curvea ONE Endodontics Files; Curvea CM Preserve Endodontics Files | — | — |
| Mani, Inc. (Head Office) | Japan | Maker | JIZAI GLIDER · MANI D FINDERS · MANI FLARE FILES · MANI FLARE FILES NiTi · +28 | — | — |
| Tangshan Zhengtong Exhibition Co., Ltd. | China | Maker | Root Canal Files, Multi Taper Assorted Files, · Short Barbed Broaches, Paste Carrier | — | — |
| Denta Craft Instruments | Pakistan | Maker | Root Canal Spreader | — | — |
| ZOGEAR Medical Co., Ltd. | China | Maker | FILE, PULP CANAL, ENDODONTIC | — | — |
| Dentag SRL | Italy | Maker | DENTAG | — | — |
| Suzhou Ramo Medical Instrument Co., Ltd. | China | Maker | AP File · EndoViewFiles Pro · RCS Blue Orifice Opener File · RCS Blue Rotary File · +31 | — | — |
| Garish Apparels | Pakistan | Maker | Tamzon Instruments Inc. | — | — |
| Shenzhen Forever Medical Devices Co., Ltd | China | Maker | Root canal file - Barbed broaches · Root canal file - C · Root canal file - F-sequence · Root canal file - Gates Drills · +19 | — | — |
| Zarc4Endo S.A. | Spain | Maker | C+ File · Hedstroem File · K File · K Flex · +15 | — | — |
| Anqing Clean Dental Instrument Technology Co Ltd | China | Maker | REAMER, PULP CANAL, ENDODONTIC /FILE, PULP CANAL, ENDODONTIC | — | — |
| Hubei Guarddent Medical Technology Co.,Ltd | China | Maker | Endo file | — | — |
| Innovative Material And Devices, Inc. | China | Maker | Stainless Steel Reamers, NiTi Reamers · NiTi MM Files, NiTi MTaper Files, NiTi MSolo Files, Gates Enlargers, Pesso Enlargers Opener,Wayfinder, Barbed Broaches · NiTi MPro Files, NiTi MPro Smart Files, NiTi MPro Blue Files, NiTi MPilot Files, NiTi ReRoot Files · NiTi TeraRossa Rotary Files, NiTi TeraRossa Hand Files, Stainless Steel TeraRossa Micro Files · +2 | — | — |
| Huizhou Videya Technology Co., Ltd. | China | Maker | VIDEYA, Root Canal Drills, Model G, P, B1, B2, M · Integrated root canal files - D · Integrated root canal files - DT · Integrated root canal files - N · +12 | — | — |
| Cangzhou Lankang Medical Instruments Developing Co., Ltd. | China | Maker | Endo ring | — | — |
| Jiangsu Yabaobao Medical Instrument Co.,Ltd. | China | Maker | ENDODONTIC PULP CANAL FILE | — | — |
| Life Science Outsourcing, Inc. | United States | Maker | 818-2131 Traverse Rotary Glide Path File - 6/.13/21mm - N · 818-2132 Traverse Rotary Glide Path File - 6/.13/25mm - N · 818-2133 Traverse Rotary Glide Path File - 6/.13/31mm - N · 818-2141 Traverse Orifice and Glide Path File - 6/.13/21mm - N · +22 | — | — |
| Onvet Medical Canada Inc. | Canada | Maker | Hedstrom Files; K-Files; T-ONE Platinum; GlidePath; Twisted Files;Adaptive Files;Non-Sterile Files | — | — |
| Henan Baistra Medical Devices Limited | China | Maker | FILE, PULP CANAL, ENDODONTIC | — | — |
| Henan Lusterdent Medical Instrument Co.,Ltd | China | Maker | Endodontic Files NiTi ( K-Files / H-Files / Reamers / C-Files / CRC Plus Files / C+ Files / U Files ); · Endodontic Files Stainless Steel ( K-Files / H-Files / Reamers / C-Files / CRC Plus Files / C+ Files / U Files ); · Endodontic Tapered NiTi Rotary Files ( Pliancy Blue Files, Pliancy Gold Files / RTM Files ); · Endodontic Tapered NiTi Rotary Files ( Pliancy Total Solution Files / G-Tiny Glide Path Files ); · +5 | — | — |
| Aadi Med Private Limited | India | Maker | Endo Paste, Endogel-RC, Endo-L | — | — |
| Hangzhou Wise Medical Device Co.,Ltd | China | Maker | File, Pulp canal | — | — |
| CDM Center of Excellence Ltd. | China | Maker | Broach, Endodontic | — | — |
| Gavin Biotechnology Co.,ltd | China | Maker | Dental root canal file · Endo files · Handle files · Rotary files | — | — |
| Easy Equipamentos Odontologicos EIRELI - EPP | Brazil | Maker | Bassi Clean File · Bassi Gutta-Percha Points · Bassi Hand Plugger · Bassi iRoot · +18 | — | — |
| Viarden Lab LLC | United States | Maker | ENDOPREP, ENDOPREP PLUS, DENCAVI, EDTA 17%, VIARZONI-T, FORMOCRESOL | — | — |
| Dongguan Wanjin Industrial Co., Ltd | China | Maker | Reamer Endodontic · File | — | — |
| Hager & Werken | Germany | Maker | PREPOMETER | — | — |
| Shandong Hengfeng Kerui Medical Equipment Co., Ltd | China | Maker | EDTA Root Canal Lubrication Gel · Dental Root Canal Instruments (Hand Files; Rotary files; Compactors; Enlargers; Paste Carrier; Barbed Broach) | — | — |
| Jordco Inc | United States | Maker | File Caddy Foam Inserts: Accessory to Endoring Files · File Caddy: Accessory to Endoring Files | — | — |
| Zhongshan Xinhe Co.,Ltd | China | Maker | File, Pulp Canal, Endodontic | — | — |
| Wuhu Guli Ortho Co.,Ltd | China | Maker | Dental root canal instruments | — | — |
| BUSCH & CO. GmbH & Co. KG | Germany | Maker | REAMER · ROOT CANAL DRILLS · ROOT CANAL FILES | — | — |
| Changsha Easyinsmile Intelligence Technology Co.,Ltd. | China | Maker | Endodontic File Models X-TAPER,G3-PRO GOLD,X-ONE,X3,X-CORN,X-PRO GOLD,X-RECIPORC,X-RETREATMENT · X-TWO-S,X-ULTRASONIC,X-BABY,X3-MAX,X-PATH,K FILE,H-FILE,R-FILE,S-FILE,C-FILE | — | — |
| Jinyuan medical equipment(tianjin)co.,ltd | China | Maker | N/A | — | — |
| Orikam Healthcare India Private Limited | India | Maker | MyEndo · MyEndo Glide File · MyEndo T Blue File · MyEndo T File · +10 | — | — |
| SKY DENT Corp for dental trading | United States | Maker | SKY DENT REAMER - 1DERFUL REAMER · SKY DENT - 1DERFUL: HEDSTROM, K-FILE, C-FILE, GO, BRAVO, CHALLENGER, NU, DUO, DISCOVERY, RE-DO. · SKY DENT NERVE BROACH - 1DERFUL NERVE BROACH | — | — |
| Chengdu Sani Medical Equipment CO.,LTD. | China | Maker | BS Rotary Endo Files, U File, Super C Root Canal Files, REAMERS Root Canal Files, K Files Root Canal Files, · H Files Root Canal Files, TAPER FILE Rotary Endo Files, G3 Rotary Endo Files, Super Pass Rotary Endo Files, · S3 Rotary Endo Files, KID Rotary Endo Files, S PRO Rotary Endo Files | — | — |
| Sino Ortho Limited | China | Maker | root canal | — | — |
| Beijing Smart Technology Co., Ltd | China | Maker | smart | — | — |
| Dongguan Integrity Medical Instrument Co.,Ltd. | China | Maker | Endodontic instruments (Gate drills, Peeso reamers) · Endodontic Root Canal Files: NiTi dental root canal files (K-files, H-files, Reamers, Spreaders, Pluggers) · Engine endodontic files(Retreatment files,PT-files,PT-files blue,PT-files gold,PT-next, Only one gold, V-silver, V-blue · Hand use files (PT-files hand use, PT-files blue hand use) · +3 | — | — |
| J C India | India | Maker | RAINBOW BLUE FLEX FILES | — | — |
| United Dental Changzhou | China | Maker | Rotary files/Root canal files, Hand use files/Manual files, Sterile Endodontic Hand Instruments | — | — |
| Zhejiang Eksen Medical Technology Co., Ltd | China | Maker | Root Canal Files | — | — |
| Creative Endodontic Technology LLC | United States | Maker | Canal Ease · Canal Pro System · H Files · K Files · +3 | — | — |
| Dhef Inc. | Taiwan | Maker | ENDO FILE | — | — |
| Ningbo Denrotary Medical Apparatus Co., Ltd. | China | Maker | Endodontic File | — | — |
| Peter Brasseler Holdings, LLC | United States | Maker | Endodontic Hand Files/ Reamer | — | — |
| Shanghai Toboom Dental Techology CO., LTD. | China | Maker | REAMER, PULP CANAL, ENDODONTIC · FILE, PULP CANAL, ENDONDONTIC · BROACH, ENDONDONTIC | — | — |
| FFDM Tivoly | France | Maker | All-Steel Engine Reamer · Hand Reamer · HEDSTROM FILE · K-FILE | — | — |
| 麦迪卡有限公司 MedicNRG Ltd | Israel | Maker | Gentlefile · Gentlefile Brush · Gentlefile Endo File | — | — |
| DEPRAG High tech Materials ( Zhengzhou ) Co.,Ltd. | China | Maker | NiTi-File | — | — |
| Hansfive (Hangzhou) Dental Technology Co., Ltd. | China | Maker | Nickel Titanium Root Canal File | — | — |
| Univy Technology Advanced Co. Ltd | China | Maker | Root canal file | — | — |
| Harald Nordin S.A. | Switzerland | Maker | REAMER | — | — |
| Prima Dental Group | United Kingdom | Maker | Prima One Gold · Prima Taper · Prima Taper Gold | — | — |
| Verdent Ltd. | Poland | Maker | Verdent endodontic instruments | — | — |
| Zhejiang Yahong Medical Apparatus Co., Ltd | China | Maker | W3 | — | — |
| Hantech Medical Device Co., Ltd. | China | Maker | EndoActivator Tips | — | — |
| J&J Instruments | United States | Maker | — | — | — |
| NN Inc Power Solutions | United States | Maker | REAMER, PULP CANAL, ENDODONTIC | — | — |
| Jining Orodeka Medical Equipment Co Ltd | China | Maker | Dental root canal instruments | — | — |
| Kazan Medical Instruments Plant | Russia | Maker | H-file manual · Barbed broaches short L-30 mm | — | — |
| Mothers Medica Private Limited | India | Maker | FLEXER | — | — |
| Shanwei Perfect Medical Instruments Co.,Ltd. | China | Maker | Dental Root-canal Instruments | — | — |
| Shanghai Xingyu Medical Equipment Co.,Ltd | China | Maker | Dental Files | — | — |
| Tianjin Gapadent Co Ltd | China | Maker | GAPA | — | — |
| BGSS Company Asia Limited | China | Maker | — | — | — |
| Foshan ORECK Medical Technology Co.,Ltd | China | Maker | Root canal enlarger (Gates drills, Pesso reamers, Fiber post drills) · Root canal file, Endodontic file | — | — |
| Reach Global India Pvt Ltd | India | Maker | ORO | — | — |
| Smarter Alloys Inc | Canada | Maker | Paradigm | — | — |
| I-Dent Innovations for Dentistry SA | Switzerland | Maker | — | — | — |
| Red Pill Endo | United States | Maker | LLJ Gradient | — | — |
| USTOMED INSTRUMENTE GmbH & Co. KG | Germany | Maker | — | — | — |
| EPDENT Co., Ltd. | South Korea | Maker | — | — | — |
| Inci Dental Tibbi Malzeme Sanayi VE Ticaret Limited Sirketi | Türkiye | Maker | — | — | — |
| J. Morita USA, Inc. | United States | Foreign exporter | RootFlex | 42 | 2022 |
| NuSmile, Ltd. | United States | Manufacturer | ApicalShaper File · BlueShaper File · BlueShaper PRO FIle · Excalibur File · +10 | 2 | 2026 |
| DSI Dental Solutions Ltd | Israel | Manufacturer | DSI ApexCream EDTA RC Preparation Cream | 2 | 2025 |
| Sonendo, Inc. | United States | Manufacturer | — | 9 | 2021 |
| Dentamerica | United States | Repacker / relabeler | ENDO FILE | 4 | 2010 |
| Engineered Endodontics | United States | Repacker / relabeler | Finishing File | 1 | 2019 |
| Sotera Health LLC | United States | Contract manufacturer | FlexAccess 04/15 21mm · FlexAccess 04/15 25mm · FlexAccess 04/15 30mm · FlexAccess 04/20 21mm · +45 | — | — |
| One Dashcorp | United States | Repacker / relabeler | Gates Glidden Drill #1, 32mm · Gates Glidden Drill #2, 32mm · Gates Glidden Drill #3, 32mm · Gates Glidden Drill #4, 32mm · +32 | — | — |
| Wuxi Lyusmile Imp and Exp Co.,ltd | China | Private-label distributor | ENDO FILE | — | — |
| Jersey Dental Supplies | United States | Repacker / relabeler | PREPARER, ROOT CANAL ENDODONTIC | — | — |
| Dentimed Sao Joao LLC | United States | Repacker / relabeler | Torino · TORINO BARBED BROACHES · TORINO GATES · TORINO K-FILES NICKEL TITANIUM · +3 | — | — |
| TitanLinks Logistics LLC | United States | Repacker / relabeler | Files | — | — |
| Jmu Dental, Inc. | United States | Repacker / relabeler | Spring Endo File | — | — |
| Patterson Companies, Inc. | United States | Foreign exporter | Patterson Peeso Endodontic drill | — | — |
| Ortho Pro Dent LLC | United States | Repacker / relabeler | Defon- Gel · RC-CREAM · Root Canal Filling Material | — | — |
| Soher Med Limited | Hong Kong SAR China | Foreign exporter | Endo file | — | — |
| STERIS Corporation | United States | Contract sterilizer | FKG8620 (BF) - EDGE EVOLVE · FKG8620 (BF) - EDGE ONE PLATINUM · FKG8620 (BF) - EDGE SEQUEL SAPPHIRE · FKG8620 (BF) - EDGE TAPER RETREAT · +26 | — | — |
| HSG-S Corp | United States | Manufacturer | Edge C-File · Edge Hedstroms · Edge K-File · Edge K-File NiTi · +11 | — | — |
| Premium Plus Dental | United States | Lister | Premium Plus Pulp Canal Instrument | — | — |
| BBF Sterilisationsservice GmbH | Germany | Contract manufacturer | HyFlex CM, HyFlex EDM | — | — |
| Ortho Arch Company Inc | United States | Repacker / relabeler | Root Canal Files | — | — |
| Diadent Group Intl., Inc. | Canada | Foreign exporter | DiaPrep Pro · H-FILE (NICKEL-TITANIUM) · Hedstrom Files · K-FILE (NICKEL-TITANIUM) · +4 | — | — |
| GoldenDent | United States | Repacker / relabeler | GoldenDent · Golden-Taper | — | — |
| Yizur Ltd | Hong Kong SAR China | Foreign exporter | Files | — | — |
| CARGUS International Inc. | United States | Repacker / relabeler | MARK3 K-Files · MARK3 Rotary Files | — | — |
| LLD Care d.o.o. | Croatia | Foreign exporter | RC-Prep | — | — |
| Shanghai Fanta Dental Materials Co., Ltd. | China | Foreign exporter | AF BABY · AF BLUE R3 · AF BLUE ROTARY · AF BLUE S ONE · +20 | — | — |
| battech | United States | Repacker / relabeler | dental plastic file holder | — | — |
| Shanghai smedent medical instrument co., ltd. | China | Foreign exporter | Starryshine | — | — |
| Toyo Medical Co. | United States | Repacker / relabeler | TOYO MEDICAL CO · TOYO MEDICAL CO. | — | — |
| Meta Dental Corp. | United States | Repacker / relabeler | MD Cleanser | — | — |
| Bina Limited | Belize | Foreign exporter | DENTAL FILE | — | — |
| Sterlab | France | Contract sterilizer | K-REAMERS · HYFLEX REMOVER · Micromega One curve Mini (sterile) · Micromega One Curve Mini procedure pack (sterile) · +13 | — | — |
| E/T Endodontic Technologies, Ltd. | Canada | Foreign exporter | MANI Reamers · CHELATE · MANI K Files · ANTAEOS BARBED BROACHES | — | — |
| Sanicure BV | Netherlands | Foreign exporter | — | — | — |
| Diaswiss, S. A. | Switzerland | Manufacturer | REAMER, PULP CANAL, ENDODONTIC · FILE, PULP CANAL, ENDODONTIC · EKW / BROACH, ENDODONTIC | — | — |
| Sure Dent Corporation | South Korea | Manufacturer | Sure-Prep | — | — |
| Common Sense Dental Products | United States | Repacker / relabeler | EndoPoint | — | — |
| 3D Dental Designs and Development LLC | United States | Contract manufacturer | — | — | — |
| Bright Supply Inc | United States | Lister | — | — | — |
| Endo Direct, LLC | United States | Repacker / relabeler | — | — | — |
| BGS Beta-Gamma-Service GmbH & Co KG | Germany | Contract sterilizer | — | — | — |
| Mainline Medical Dental Supply | Canada | Foreign exporter | — | — | — |
| MHM Grupo Diamante, S.A. de C.V. | Mexico | Foreign exporter | — | — | — |
| Oketz Logistics LLC | United States | Repacker / relabeler | — | — | — |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
Where endodontic files are made
Number of makers in this category with a manufacturing establishment in the country.
FDA device types in this category
| Device type | Class | Regulation | Makers | Clearances |
|---|---|---|---|---|
| Endodontic Pulp Canal FileEKS | 1 | 872.4565 | 106 | 31 |
| Root Canal Endodontic PreparerEKQ | 1 | 872.4565 | 32 | 2 |
| Endodontic Pulp Canal ReamerEKP | 1 | 872.4565 | 30 | 6 |
| Endodontic BroachEKW | 1 | 872.4565 | 21 | 7 |
Recent clearances
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 13 Dec 2006 | K062856 | TF ROTARY NICKEL TITANIUM FILE | Sybron Dental Specialties | EKS Endodontic Pulp Canal File |
| 28 Mar 2001 | K004031 | NT SWIFT; TI\TEC; GATES GLIDDEN DRILLS; DENTAL POWER ENDODONTIC HAND FILES | Dental Power, Inc. | EKS Endodontic Pulp Canal File |
| 22 May 1997 | K971319 | NT SERIES ENDODONTIC FILES, MAC SERIES ENDODONTIC FILES | Tycom Dental | EKS Endodontic Pulp Canal File |
| 16 May 1997 | K970649 | HERO 642 | Coltene/Whaledent AG | EKS Endodontic Pulp Canal File |
| 4 Jun 1996 | K962031 | QUANTEC SERIES 2000 ENDODONTIC FILES | Tycom Dental | EKS Endodontic Pulp Canal File |
| 28 Sep 1995 | K953604 | SHAPING HEDSTROM N.T. | Sybron Dental Specialties | EKS Endodontic Pulp Canal File |
| 3 Jan 1994 | K935542 | NICKEL-TITANIUM K-TYPE FILE | Union Broach, Div. Moyco Industries, Inc. | EKS Endodontic Pulp Canal File |
| 4 Nov 1993 | K932529 | LIGHTSPEED DENTAL HAND INSTRUMENT | Lightspeed Endodontics | EKS Endodontic Pulp Canal File |
| 20 Oct 1993 | K933582 | PROFILE SERIES 29 FILES | Dentsply Sirona, Inc. | EKS Endodontic Pulp Canal File |
| 3 Apr 1991 | K902018 | DENTAURUM CERAMIC DEBONDING UNIT | Dentauraum, Inc. | EKS Endodontic Pulp Canal File |
| 5 Mar 1991 | K905640 | SOLID CORE GUTTA PERCHA CARRIER | The Hygenic Company, LLC | EKS Endodontic Pulp Canal File |
| 5 Mar 1991 | K905461 | PROCEDURE KIT/ROUTINE DENTAL PROCEDURES | Angiosystems, Inc. | EKS Endodontic Pulp Canal File |
| 14 Aug 1990 | K901037 | VISIONER 21-A | J. Morita USA, Inc. | EKS Endodontic Pulp Canal File |
| 31 May 1990 | K897195 | A-COMPANY ELECTROTHERMAL DEBONDING DEVICE (ETD) | A Company, Inc. | EKS Endodontic Pulp Canal File |
| 24 Oct 1989 | K883418 | DE-BOND 200 | Scheu-Dental | EKS Endodontic Pulp Canal File |
| 15 Sep 1989 | K892861 | DENTAL PIK | U.S. Dentek Corp. | EKS Endodontic Pulp Canal File |
| 24 May 1989 | K892894 | S-FILE, S-FINDER, S-ENGINE FILE | Svenska Dental Instruments AB | EKS Endodontic Pulp Canal File |
| 27 Oct 1987 | K873671 | COLTENE PRESIDENT JET IMPRESSION MATERIALS SYSTEM | Coltene AG | EKS Endodontic Pulp Canal File |
| 24 Jun 1987 | K871493 | DENTI-TRAY(TM) | Advanced Medical, Inc. | EKW Endodontic Broach |
| 27 May 1987 | K870765 | CANNULATED INSTRUMENT CLEANERS | Treace Medical, Inc. | EKW Endodontic Broach |
| 27 Feb 1987 | K864976 | SOLUSET CALCIUM DEMINERALIZING SOLUTION | Endo Technic Corp. | EKS Endodontic Pulp Canal File |
| 19 Feb 1987 | K870177 | ENDOBRUSH | C & S Microinstruments , Ltd. | EKS Endodontic Pulp Canal File |
| 19 Feb 1987 | K864922 | DENTAL HANDPIECES AND ATTACHMENT | E&D Dental Manufacturing Co. | EKS Endodontic Pulp Canal File |
| 1 Aug 1986 | K862523 | MAN SURG INSTR/ACCESS DUMBACH TITAN MESH IMPL SYS | Walter Lorenz Surgical, Inc. | EKW Endodontic Broach |
| 6 Mar 1986 | K855136 | FLEXOR FLEXIBLE ROANE TIP ENDODONTIC FILE | Union Broach, Div. Moyco Industries, Inc. | EKS Endodontic Pulp Canal File |
| 4 Oct 1983 | K832378 | VIBRATORY ENDODONTIC SYSTEM | Syntex Dental Products, Inc. | EKQ Root Canal Endodontic Preparer |
| 12 Jul 1983 | K831749 | ENDODONTIC BROACH(76EKN) BARBED BROACH | Union Branch | EKW Endodontic Broach |
| 28 Dec 1982 | K823685 | FILE TYPE H (HEDSTROEM) ENDODONTIC | United Dental Mfg., Inc. | EKS Endodontic Pulp Canal File |
| 28 Dec 1982 | K823684 | FILE TYPE K ENDODONTIC | United Dental Mfg., Inc. | EKS Endodontic Pulp Canal File |
| 28 Dec 1982 | K823686 | REAMER TYPE K ENDODONTIC | United Dental Mfg., Inc. | EKP Endodontic Pulp Canal Reamer |
| 15 Dec 1982 | K823489 | ENDODONTIC BROACH-BARBED BROACH | Union Broach, Div. Moyco Industries, Inc. | EKW Endodontic Broach |
| 24 Nov 1982 | K823318 | DENTAL INSTRUMENTS - EXCAVATORS | Miltex, Inc. | EKS Endodontic Pulp Canal File |
| 24 Nov 1982 | K823316 | DENTAL INSTRUMENTS - FILES | Miltex, Inc. | EKS Endodontic Pulp Canal File |
| 28 Sep 1982 | K822622 | ROOT CANAL FILES, TYPE H (HEDSTROM | Union Broach, Div. Moyco Industries, Inc. | EKS Endodontic Pulp Canal File |
| 28 Sep 1982 | K822621 | ROOT CANAL FILES, TYPE K | Union Broach, Div. Moyco Industries, Inc. | EKS Endodontic Pulp Canal File |
| 28 Sep 1982 | K822620 | ROOT CANAL REAMERS, TYPE K | Union Broach, Div. Moyco Industries, Inc. | EKP Endodontic Pulp Canal Reamer |
| 23 Oct 1981 | K812692 | FILES & REAMERS | Miltex Instrument Co. | EKS Endodontic Pulp Canal File |
| 25 Aug 1981 | K812260 | DYNA TRAK ENDODONTIC PREP. INSTRUMENT | Inventive Technology Int'L., Inc. | EKS Endodontic Pulp Canal File |
| 21 Jul 1980 | K801463 | OJ-1 ENDODONIC ROOT CANAL FILE HOLDER | Almore Intl., Inc. | EKQ Root Canal Endodontic Preparer |
| 19 Feb 1980 | K800293 | FILE, PULP CANAL | Ipco Corp. | EKS Endodontic Pulp Canal File |