Surgical devices · 21 CFR 872 Subpart E
Endodontic Pulp Canal File
FDA device type “File, Pulp Canal, Endodontic”.
- Companies listing it
- 145106 makers
- Brands and models
- 1,844
- 510(k) clearances
- 310 in five years
- FDA name
- File, Pulp Canal, Endodontic
510(k) clearances per year, 1976–2026
Companies that list EKS
145 companies currently list this device type with FDA.
| Company | Country | Role | Brands and models listed | Clearances | Latest |
|---|---|---|---|---|---|
| Dentsply Sirona, Inc. | United States | Maker | — | 148 | 2026 |
| Voco GmbH | Germany | Maker | Reamer | 117 | 2026 |
| DiaDent Group International | South Korea | Maker | DIA-X FILE · H-FILE (NICKEL-TITANIUM) · Hedstrom Files · K-FILE (NICKEL-TITANIUM) · +3 | 24 | 2026 |
| Sybron Dental Specialties | United States | Maker | Barbed Broach · Hedstrom Files · K-Files · K-Flex Files · +20 | 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 |
| Meta Biomed Co, Ltd | United States | Maker | Aurum · GL153 | 24 | 2024 |
| 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 | Disposable Sterile Root Canal File · Root Canal File · Sterile Root Canal File | 3 | 2026 |
| Hager& Meisinger GmbH | Germany | Maker | MEISINGER | 14 | 2025 |
| Pac-Dent Inc. | United States | Maker | JS Dental | 5 | 2022 |
| Beijing C-Root Dental Medical Devices Co., LTD. | China | Maker | C-Root File | 2 | 2024 |
| Coltene/Whaledent AG | Switzerland | Maker | H-Files · HEDSTROEM FILES · HEDSTROEM FILES Prime Line · HERO 642 · +28 | 45 | 2022 |
| 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 |
| 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 · +40 | 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 | EDTA · 17% SOLUTION | 107 | 2021 |
| Angelus Industria DE Produtos Odontologicos S/A | Brazil | Maker | Nexis Endodontic Files | 11 | 2021 |
| Micron Corporation | Japan | Maker | M-Tip | 5 | 2018 |
| GNI Co., LTD | South Korea | Maker | Endo | 3 | 2021 |
| Integra LifeSciences Corporation | United States | Maker | Flex-R · Hi-5 · Liberator · Miltex · +2 | 2 | 2014 |
| B&L Biotech Co., Ltd. | South Korea | Maker | CI120-A · CI120-E · CI90-A · CI90-E · +97 | 1 | 2006 |
| Directa AB | Sweden | Maker | H-file · K-file · S-file · s-finder | 1 | 2015 |
| COLTENE Holding AG | Switzerland | Maker | HyFlex CM, HyFlex EDM | 1 | 2003 |
| Gebr. Brasseler GmbH & Co. KG | Germany | Maker | KOMET ENDODONTIC ROOT CANAL FILE, K-FILE, HEDSTROEM FILE | 1 | 2007 |
| 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 | Endoperfection Hand C-Files (SSt), 10, 21 · Endoperfection Hand C-Files (SSt), 10, 25 · Endoperfection Hand C-Files (SSt), 12, 21 · Endoperfection Hand C-Files (SSt), 12, 25 · +504 | — | — |
| 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 · +40 | — | — |
| 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 | — | — |
| 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 | BC PASTE FILLER · BioRace · BT-Race · Edge Evolve · +41 | — | — |
| Medcave Private Limited | Pakistan | Maker | File Endodontic | — | — |
| Shanghai Dochem Industries Co., Ltd. | China | Maker | Niti/Stainless Steel Endo File | — | — |
| 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 · +24 | — | — |
| Tangshan Zhengtong Exhibition Co., Ltd. | China | Maker | Root Canal Files, Multi Taper Assorted Files, · Short Barbed Broaches, Paste Carrier | — | — |
| ZOGEAR Medical Co., Ltd. | China | Maker | FILE, PULP CANAL, ENDODONTIC | — | — |
| 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 | — | — |
| Hubei Guarddent Medical Technology Co.,Ltd | China | Maker | Endo file | — | — |
| Innovative Material And Devices, Inc. | China | Maker | 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 · Root Fillers, NiTi H Files, NiTi K Files, Stainless Steel CPilot Files, Stainless Steel H Files, · +1 | — | — |
| Huizhou Videya Technology Co., Ltd. | China | Maker | Integrated root canal files - D · Integrated root canal files - DT · Integrated root canal files - N · Integrated root canal files - O · +10 | — | — |
| 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 ); · +4 | — | — |
| Hangzhou Wise Medical Device Co.,Ltd | China | Maker | File, Pulp canal | — | — |
| 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 | — | — |
| Hager & Werken | Germany | Maker | PREPOMETER | — | — |
| Shandong Hengfeng Kerui Medical Equipment Co., Ltd | China | Maker | 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 | 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 - 1DERFUL: HEDSTROM, K-FILE, C-FILE, GO, BRAVO, CHALLENGER, NU, DUO, DISCOVERY, RE-DO. | — | — |
| 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) · +2 | — | — |
| 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 | — | — | — |
| Shanghai Toboom Dental Techology CO., LTD. | China | Maker | FILE, PULP CANAL, ENDONDONTIC | — | — |
| FFDM Tivoly | France | Maker | 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 | — | — |
| 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 | — | — |
| Jining Orodeka Medical Equipment Co Ltd | China | Maker | Dental root canal instruments | — | — |
| Kazan Medical Instruments Plant | Russia | Maker | H-file manual | — | — |
| 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 file, Endodontic file | — | — |
| Reach Global India Pvt Ltd | India | Maker | ORO | — | — |
| Smarter Alloys Inc | Canada | Maker | Paradigm | — | — |
| Red Pill Endo | United States | Maker | LLJ Gradient | — | — |
| 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 |
| 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 | — | — |
| Dentimed Sao Joao LLC | United States | Repacker / relabeler | TORINO BARBED BROACHES · TORINO GATES · TORINO K-FILES NICKEL TITANIUM · TORINO K-FILES STAINLESS STEEL · +2 | — | — |
| TitanLinks Logistics LLC | United States | Repacker / relabeler | Files | — | — |
| Jmu Dental, Inc. | United States | Repacker / relabeler | Spring Endo File | — | — |
| 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 · +10 | — | — |
| 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 | H-FILE (NICKEL-TITANIUM) · Hedstrom Files · K-FILE (NICKEL-TITANIUM) · K-Files · +2 | — | — |
| GoldenDent | United States | Repacker / relabeler | Golden-Taper | — | — |
| Yizur Ltd | Hong Kong SAR China | Foreign exporter | Files | — | — |
| CARGUS International Inc. | United States | Repacker / relabeler | MARK3 K-Files · MARK3 Rotary Files | — | — |
| 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. | — | — |
| Dongguan Wanjin Industrial Co., Ltd | China | Manufacturer | File | — | — |
| Bina Limited | Belize | Foreign exporter | DENTAL FILE | — | — |
| Sterlab | France | Contract sterilizer | HYFLEX REMOVER · Micromega One curve Mini (sterile) · Micromega One Curve Mini procedure pack (sterile) · Micromega One Gilder (sterile) · +12 | — | — |
| E/T Endodontic Technologies, Ltd. | Canada | Foreign exporter | MANI K Files | — | — |
| Sanicure BV | Netherlands | Foreign exporter | — | — | — |
| Diaswiss, S. A. | Switzerland | Manufacturer | FILE, PULP CANAL, ENDODONTIC | — | — |
| 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 | — | — | — |
510(k) clearances
| Decided | 510(k) | Device | Applicant |
|---|---|---|---|
| 13 Dec 2006 | K062856 | TF ROTARY NICKEL TITANIUM FILE | Sybron Dental Specialties |
| 28 Mar 2001 | K004031 | NT SWIFT; TI\TEC; GATES GLIDDEN DRILLS; DENTAL POWER ENDODONTIC HAND FILES | Dental Power, Inc. |
| 22 May 1997 | K971319 | NT SERIES ENDODONTIC FILES, MAC SERIES ENDODONTIC FILES | Tycom Dental |
| 16 May 1997 | K970649 | HERO 642 | Coltene/Whaledent AG |
| 4 Jun 1996 | K962031 | QUANTEC SERIES 2000 ENDODONTIC FILES | Tycom Dental |
| 28 Sep 1995 | K953604 | SHAPING HEDSTROM N.T. | Sybron Dental Specialties |
| 3 Jan 1994 | K935542 | NICKEL-TITANIUM K-TYPE FILE | Union Broach, Div. Moyco Industries, Inc. |
| 4 Nov 1993 | K932529 | LIGHTSPEED DENTAL HAND INSTRUMENT | Lightspeed Endodontics |
| 20 Oct 1993 | K933582 | PROFILE SERIES 29 FILES | Dentsply Sirona, Inc. |
| 3 Apr 1991 | K902018 | DENTAURUM CERAMIC DEBONDING UNIT | Dentauraum, Inc. |
| 5 Mar 1991 | K905640 | SOLID CORE GUTTA PERCHA CARRIER | The Hygenic Company, LLC |
| 5 Mar 1991 | K905461 | PROCEDURE KIT/ROUTINE DENTAL PROCEDURES | Angiosystems, Inc. |
| 14 Aug 1990 | K901037 | VISIONER 21-A | J. Morita USA, Inc. |
| 31 May 1990 | K897195 | A-COMPANY ELECTROTHERMAL DEBONDING DEVICE (ETD) | A Company, Inc. |
| 24 Oct 1989 | K883418 | DE-BOND 200 | Scheu-Dental |
| 15 Sep 1989 | K892861 | DENTAL PIK | U.S. Dentek Corp. |
| 24 May 1989 | K892894 | S-FILE, S-FINDER, S-ENGINE FILE | Svenska Dental Instruments AB |
| 27 Oct 1987 | K873671 | COLTENE PRESIDENT JET IMPRESSION MATERIALS SYSTEM | Coltene AG |
| 27 Feb 1987 | K864976 | SOLUSET CALCIUM DEMINERALIZING SOLUTION | Endo Technic Corp. |
| 19 Feb 1987 | K870177 | ENDOBRUSH | C & S Microinstruments , Ltd. |
| 19 Feb 1987 | K864922 | DENTAL HANDPIECES AND ATTACHMENT | E&D Dental Manufacturing Co. |
| 6 Mar 1986 | K855136 | FLEXOR FLEXIBLE ROANE TIP ENDODONTIC FILE | Union Broach, Div. Moyco Industries, Inc. |
| 28 Dec 1982 | K823685 | FILE TYPE H (HEDSTROEM) ENDODONTIC | United Dental Mfg., Inc. |
| 28 Dec 1982 | K823684 | FILE TYPE K ENDODONTIC | United Dental Mfg., Inc. |
| 24 Nov 1982 | K823318 | DENTAL INSTRUMENTS - EXCAVATORS | Miltex, Inc. |
| 24 Nov 1982 | K823316 | DENTAL INSTRUMENTS - FILES | Miltex, Inc. |
| 28 Sep 1982 | K822622 | ROOT CANAL FILES, TYPE H (HEDSTROM | Union Broach, Div. Moyco Industries, Inc. |
| 28 Sep 1982 | K822621 | ROOT CANAL FILES, TYPE K | Union Broach, Div. Moyco Industries, Inc. |
| 23 Oct 1981 | K812692 | FILES & REAMERS | Miltex Instrument Co. |
| 25 Aug 1981 | K812260 | DYNA TRAK ENDODONTIC PREP. INSTRUMENT | Inventive Technology Int'L., Inc. |
| 19 Feb 1980 | K800293 | FILE, PULP CANAL | Ipco Corp. |
Official records: FDA product classification for EKS · 21 CFR 872.4565.
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026