Surgical devices · 21 CFR 872 Subpart E
Endodontic Root Canal Plugger
FDA device type “Plugger, Root Canal, Endodontic”.
- Companies listing it
- 12895 makers
- Brands and models
- 432
- 510(k) clearances
- 60 in five years
- FDA name
- Plugger, Root Canal, Endodontic
510(k) clearances per year, 1976–2026
Companies that list EKR
128 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 |
| DiaDent Group International | South Korea | Maker | Dia-Duo · Duo-Gun · Duo-Pen | 24 | 2026 |
| Guilin Woodpecker Medical Instrument Co., Ltd. | China | Maker | Gutta Percha Obturation Device, Fi-P, Fi-G, Fi-E | 12 | 2025 |
| Sybron Dental Specialties | United States | Maker | Buchanan Hand Plugger · Condensor · elements IC · Elements Obturation Cartridge · +3 | 203 | 2026 |
| KLS Martin SE & Co. KG | Germany | Maker | — | 43 | 2026 |
| Inter-Med, Inc. | United States | Maker | Vista CT4 Tip · Vista CT7 Tip | 7 | 2026 |
| Meta Biomed Co, Ltd | United States | Maker | EQ Condenser · EQ-V | 24 | 2024 |
| Premier Dental Products Company | United States | Maker | Premier Endodontic Pluggers | 28 | 2026 |
| Young Innovations Inc | United States | Maker | AEI Pluggers · Obtura III Max · Obtura MaxPack · Obtura Spartan | 23 | 2025 |
| Changzhou Sifary Medical Technology Co., Ltd. | China | Maker | Endodontic Obturation Device, Fast-Fill, Fast-Pack pro · Endodontic Obturation Device, Space-Fill, Space-Pack · Z-Up; Z-Down | 4 | 2026 |
| Guilin Refine Medical Instrument Co., LTD. | China | Maker | Gutta Percha Obturation System, MaxFill-G, MaxFill-P | 3 | 2026 |
| Dentalez, Inc. | United States | Maker | Hand Instruments - Pluggers | 9 | 2026 |
| W&H Dentalwerk Buermoos GmbH | Austria | Maker | — | 17 | 2026 |
| DentalMaster (Xiamen) Medical Technology Co., Ltd. | China | Maker | PTFE Tape Press Instrument | 1 | 2026 |
| Shenzhen Superline Technology Co Ltd | China | Maker | Deltajet · Fliex · NIC · Obturation System(Alpha Fill-System, Alpha Fill-G, Alpha Fill-P) · +3 | 1 | 2025 |
| Denjoy Dental Co., Ltd. | China | Maker | Integrated Endo System (Meet Endo-II) · JAS Activator · JAS Activator Ultrasonic Tips · JAS Charging Unit · +9 | 1 | 2025 |
| Aseptico, Inc. | United States | Maker | A111000000000 - Calamus Heated Plugger - Small · A112000000000 - Calamus Heated Plugger - Medium · A113000000000 - Calamus Heated Plugger - Large · A115000000000 - Calamus thermal response · +48 | 17 | 2015 |
| Hu-Friedy Mfg Co., LLC | United States | Maker | Hu-Friedy Mfg Co.,LLC · PLUGGER · ROOT CANAL | 8 | 2012 |
| Dxm Co., Ltd. | South Korea | Maker | DX-Condenser · Endopex · Friendo · Friendo Pen Tip · +3 | 6 | 2020 |
| Asi Medical, Inc. | United States | Maker | Advanced Dental System · Advanced Endodontic System · Triton Dental System | 5 | 2013 |
| Apoza Enterprise Co., Ltd. | Taiwan | Maker | GP Series | 5 | 2007 |
| Storz AM Mark GmbH | Germany | Maker | Root canal plugger | 2 | 2008 |
| B&L Biotech Co., Ltd. | South Korea | Maker | AC adaptor protector cap · Alpha · Alpha Enclosure · Alpha II · +98 | 1 | 2006 |
| Directa AB | Sweden | Maker | Finger Plugger | 1 | 2015 |
| Arnold Tuber Industries | United States | Maker | Plugger | 1 | 2009 |
| BioMTA | South Korea | Maker | OrhtoMTA Plugger | 1 | 2014 |
| Schlumbohm GmbH & Co. KG | Germany | Maker | EndoPilot | 1 | 2021 |
| Osung Mnd Co Ltd | South Korea | Maker | RCP1-3 · RCP10 · RCP11 · RCP5-7 · +3 | — | — |
| ErgoDenta ApS | Denmark | Maker | Endo Plugger, 0.5mm-1mm · Endo Spreader 0.4mm & Plugger 0.4mm · Endo Spreader 0.4mm & Plugger 0.6mm · Endo Spreader 0.6mm & Plugger 0.8mm · +6 | — | — |
| Densol International (Private) Limited | Pakistan | Maker | Bone Grafting Compactor Serrated 3/4mm · Bone Grafting Compactor Serrated 6/8mm · Bone Grafting Lebanca Plugger · Bone Grafting Memebrane Placement Instrument · +13 | — | — |
| Endoperfection Ltd | United Kingdom | Maker | Finger Pluggers (NiTi), 15, 21 · Finger Pluggers (NiTi), 15, 25 · Finger Pluggers (NiTi), 20, 21 · Finger Pluggers (NiTi), 20, 25 · +20 | — | — |
| Schobell Industrial Ltda | Brazil | Maker | Double - Ended Plugger 112 · Micro Plugger D1 | — | — |
| Shanghai Kangqiao Dental Instruments Factory | China | Maker | Bone powder pluggers Type G/I/III · Cement pluggers E1 / E2# / E3 / E4 (eight-angle handle) · Cement pluggers KCP2 · Cement pluggers R1/R2/R3/R4 (round handle) · +12 | — | — |
| Guilin Yikeshi Medical Instrument Co Ltd | China | Maker | Obturation System · xp-34 · xp-34s · xp-35 · +13 | — | — |
| B. Ali Impex | Pakistan | Maker | BALI · DOCTOR NICE · NIVO · SHARK | — | — |
| Prodont-Holliger | France | Maker | MACHTOU 1-1 reference 4191SI -burnisher machtou 1-1 bliss · MACHTOU 1-2 reference 4192SI-burnisher machtou 1-2 bliss · MACHTOU 2-3 reference 4193SI -burnisher machtou 2-3 bliss · MACHTOU 2-4 reference 4194SI-burnisher machtou 2-4 bliss | — | — |
| Dental Studio | South Korea | Maker | CORD PACKERS · ROOT CANAL PLUGGERS | — | — |
| Shenzhen Denco Medical Co Ltd | China | Maker | Gutta Percha Obturation Device;Plugger;Gutta Cutter | — | — |
| Aspen Surgical Products | United States | Maker | Symmetry Surgical | — | — |
| Technimen Skillers | Pakistan | Maker | AMALGAM CONDENSERS AND PLUGGERS, Amalgam Carrier, Amalgam Well, | — | — |
| Cislak Manufacturing, Inc. | United States | Maker | Cislak · Zoll Dental | — | — |
| Falcon Surgical Co. (Pvt.) Ltd. | Pakistan | Maker | Plugger | — | — |
| Pomee Corporation | Pakistan | Maker | Black Pluggar 1/2 · Plugger#0/1 · Root Canal s/m s/c Diit | — | — |
| Commic Surgico | Pakistan | Maker | Amalgam plugger DE Black Nr. 1 · Amalgam plugger DE Black Nr. 2 · Amalgam plugger Hollenback H1/2-3 · Amalgam plugger serrated Nr. 0 · +5 | — | — |
| FKG Dentaire Sarl | Switzerland | Maker | FKG · Pluggers | — | — |
| Medcave Private Limited | Pakistan | Maker | Plugger Endodontic | — | — |
| Nordent MFG., Inc. | United States | Maker | Nordent Endo Plugger | — | — |
| Panorama International | Pakistan | Maker | PLUGGER, ROOT CANAL, ENDODONTIC | — | — |
| Accompany Surgical | Pakistan | Maker | AMALGAM CONDENSERS AND PLUGGERS | — | — |
| Lacigrus International | Pakistan | Maker | PLUGGER, ROOT CANAL, ENDODONTIC | — | — |
| Comfort Surgical Instruments | Pakistan | Maker | Root canal plugger | — | — |
| Aesculap AG | Germany | Maker | Aesculap | — | — |
| PDT Inc. | United States | Maker | PDT, Inc. | — | — |
| Adolf Schweick Hardt GmbH & Co | Germany | Maker | ROOT CANAL PLUGGERS | — | — |
| Beyes Dental Inc | Canada | Maker | CORDLESS GUTTA PERCHA OBTURATION SYSTEM, P1;P2;P3;F1;F2;F3 | — | — |
| Confident Instruments | Pakistan | Maker | Artman Instruments | — | — |
| Mani, Inc. (Head Office) | Japan | Maker | FINGER PLUGGER · MANI PLUGGERS · PLUGGER | — | — |
| Denta Craft Instruments | Pakistan | Maker | AMALGAM CONDENSERS AND PLUGGERS | — | — |
| ZOGEAR Medical Co., Ltd. | China | Maker | PLUGGER, ROOT CANAL, ENDODONTIC | — | — |
| Medisporex Private Limited | Pakistan | Maker | MEDIS | — | — |
| Dentag SRL | Italy | Maker | DENTAG | — | — |
| Suzhou Ramo Medical Instrument Co., Ltd. | China | Maker | RCS Plugger | — | — |
| Shenzhen Forever Medical Devices Co., Ltd | China | Maker | PLUGGER | — | — |
| Surgicrafts | Pakistan | Maker | EKR / PLUGGER, ROOT CANAL, ENDODONTIC | — | — |
| Goldman Products, Inc. | United States | Maker | Goldman · MicroDent | — | — |
| Harf Industries | Pakistan | Maker | Calcium-Hydroxide Placer · PLUGGER, ROOT CANAL, ENDODONTIC · Root Canal Plugger, Endodontic Instruments, 1/Pk · Rubber Dam Punch Ainsworth · +2 | — | — |
| Innovative Material And Devices, Inc. | China | Maker | NiTi Pluggers, Stainless Steel Pluggers | — | — |
| Silver Plus Corp. | Pakistan | Maker | PLUGGER, ROOT CANAL, ENDODONTIC | — | — |
| Shanghai Medical Instruments (Group) Ltd. Corp. | China | Maker | ROOT PLUGGER | — | — |
| Lohar Medical Company | Pakistan | Maker | EKR / PLUGGER, ROOT CANAL, ENDODONTIC | — | — |
| Mident Ltd | United Kingdom | Maker | Root Pluggers And Spreaders | — | — |
| Y. Z. Corporation | Pakistan | Maker | YZ Endodontic Pluggers | — | — |
| Nopa Instruments Medizintechnik GmbH | Germany | Maker | PLUGGER · ROOT CANAL | — | — |
| B. Braun Medical Industries Sdn. Bhd | Malaysia | Maker | Aesculap | — | — |
| CDM Center of Excellence Ltd. | China | Maker | Plugger, Root Canal, Endodontic | — | — |
| Central Surgical Co. Pvt. Ltd. | Pakistan | Maker | PLUGGER, ROOT CANAL, ENDODONTIC | — | — |
| BUSCH & CO. GmbH & Co. KG | Germany | Maker | ROOT FILLERS | — | — |
| SKY DENT Corp for dental trading | United States | Maker | SKY DENT PLUGGER - 1DERFUL PLUGGER | — | — |
| SITEC (Pvt.) Ltd. | Pakistan | Maker | Plugger, Root Canal, Endodontic | — | — |
| Power Dental USA | United States | Maker | — | — | — |
| Avilign Medical | Pakistan | Maker | Plugger, Root Canal, Endodontic | — | — |
| United Dental Changzhou | China | Maker | Plugger | — | — |
| Peter Brasseler Holdings, LLC | United States | Maker | — | — | — |
| Shanghai Toboom Dental Techology CO., LTD. | China | Maker | PLUGGER, ROOT CANAL, ENDODONTIC | — | — |
| J&J Instruments | United States | Maker | — | — | — |
| medmix Switzerland AG | Switzerland | Maker | PLUGGER, ROOT CANAL, ENDODONTIC | — | — |
| Hermann Mueller Medizintechnik GmbH | Germany | Maker | — | — | — |
| Phoenix Instruments, Inc. | United States | Maker | — | — | — |
| USTOMED INSTRUMENTE GmbH & Co. KG | Germany | Maker | — | — | — |
| Xinhua Surgical Instrument Co.,Ltd. | China | Maker | — | — | — |
| Devemed GmbH | Germany | Maker | — | — | — |
| EPDENT Co., Ltd. | South Korea | Maker | — | — | — |
| Helmut Zepf Medizintechnik GmbH | Germany | Maker | — | — | — |
| Nextcon International | Pakistan | Maker | — | — | — |
| RZ Medizintechnik GmbH | Germany | Maker | — | — | — |
| B.t.i. Biotechnology | Spain | Foreign exporter | — | 14 | 2024 |
| Pac-Dent Inc. | United States | Contract manufacturer | FINGER PLUGGER · JS Dental | 5 | 2022 |
| NuSmile, Ltd. | United States | Manufacturer | Z Micro-Opener · Z Micro-Shaper · Z-DOWN System · Z-UP System | 2 | 2026 |
| Pulpdent Corporation | United States | Manufacturer | Root Canal Plugger | 107 | 2021 |
| Jedmed Instrument Co. | United States | Repacker / relabeler | PLUGGER · RUBENSTEIN | 4 | 1981 |
| Integra LifeSciences Corporation | United States | Contract manufacturer | Integra · Miltex | 2 | 2014 |
| Aesculap, Inc. | United States | Lister | Aesculap | 2 | 2006 |
| Gebr. Brasseler GmbH & Co. KG | Germany | Contract manufacturer | D-PACK HEATING TIPS · EndoPilot² · Gutta Percha Obturation Device, Fi-P, Fi-G, Fi-E · Obtura Needle Lock Nuts, Thermal Protectors, Applicator Needles, | 1 | 2007 |
| One Dashcorp | United States | Repacker / relabeler | Valdent USA #35 - #70 Stainless Steel Gutta-Percha Plugger · Valdent USA #40 - #80 Stainless Steel Gutta-Percha Plugger · Valdent USA #50 - #100 Stainless Steel Gutta-Percha Plugger · Valdent USA #60 - #120 Stainless Steel Gutta-Percha Plugger | — | — |
| Dentimed Sao Joao LLC | United States | Repacker / relabeler | Torino | — | — |
| TitanLinks Logistics LLC | United States | Repacker / relabeler | plugger | — | — |
| Jmu Dental, Inc. | United States | Repacker / relabeler | Obturation System | — | — |
| Patterson Companies, Inc. | United States | Foreign exporter | Patterson Endodontic Plugger | — | — |
| Soher Med Limited | Hong Kong SAR China | Foreign exporter | dental instrument | — | — |
| HSG-S Corp | United States | Manufacturer | EdgeEndo® · EdgeFlow · EdgePack | — | — |
| Premium Plus Dental | United States | Lister | — | — | — |
| Diadent Group Intl., Inc. | Canada | Foreign exporter | Dia-Duo · Duo-Gun · Duo-Pen | — | — |
| GoldenDent | United States | Repacker / relabeler | Gutta Percha Obturation Device, Fi-P, Fi-G, Fi-E, Plugger | — | — |
| Yizur Ltd | Hong Kong SAR China | Foreign exporter | Plugger | — | — |
| TBS Dental | United States | Repacker / relabeler | TBS INOX USA | — | — |
| Zarc4Endo S.A. | Spain | Private-label distributor | Z Micro-Opener · Z Micro-Shaper · Z-DOWN System · Z-UP System | — | — |
| Shanghai Fanta Dental Materials Co., Ltd. | China | Foreign exporter | — | — | — |
| Shanghai smedent medical instrument co., ltd. | China | Foreign exporter | Starryshine | — | — |
| YCH Distripark Sdn Bhd | Malaysia | Foreign exporter | Aesculap | — | — |
| Dental Brands for Less | Canada | Foreign exporter | KERR | — | — |
| E/T Endodontic Technologies, Ltd. | Canada | Foreign exporter | MANI Finger Pluggers | — | — |
| Sanicure BV | Netherlands | Foreign exporter | — | — | — |
| Enova Illumination Inc. | United States | Lister | Gutta Percha Obturation Device, Fi-P, Fi-G, Fi-E | — | — |
| Novo Surgical Inc. | United States | Repacker / relabeler | — | — | — |
| Kash Sales Inc. | Canada | Foreign exporter | — | — | — |
| 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 |
|---|---|---|---|
| 5 Jun 2006 | K060347 | B&L L-BETA, MODEL WL-B1 | B&L Biotech Co., Ltd. |
| 1 Dec 2004 | K042828 | OBTURA GUTTA PERCHA DELIVERY SYSTEM, MODEL 823-700 | Young O/S, LLC |
| 28 Apr 2004 | K031664 | ELEMENTS OBTURATION UNIT | Sybron Endo/Analytic |
| 26 Mar 1986 | K860569 | ENDODONTIC ROOT CANAL PLUGGER | Dentsply Intl., Inc. |
| 12 Jul 1983 | K831748 | ENDODONTIC ROOT CANAL PLUGGER FINGER- | Union Branch |
| 3 Aug 1979 | K791019 | MCSPADDEN CONDENSOR | Techdent, Inc. |
Official records: FDA product classification for EKR · 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