Surgical devices · 21 CFR 872 Subpart E
Endodontic Pulp Canal Filling Material Spreader
FDA device type “Spreader, Pulp Canal Filling Material, Endodontic”.
- Companies listing it
- 8369 makers
- Brands and models
- 150
- 510(k) clearances
- 10 in five years
- FDA name
- Spreader, Pulp Canal Filling Material, Endodontic
510(k) clearances per year, 1976–2026
Companies that list EKK
83 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 |
| Guilin Woodpecker Medical Instrument Co., Ltd. | China | Maker | Root Canal (Endodontic) | 12 | 2025 |
| Sybron Dental Specialties | United States | Maker | Finger Spreaders | 203 | 2026 |
| Premier Dental Products Company | United States | Maker | Premier Endodontic Spreaders | 28 | 2026 |
| Young Innovations Inc | United States | Maker | AEI Spreaders | 23 | 2025 |
| Dentalez, Inc. | United States | Maker | Hand Instrument - Spreaders | 9 | 2026 |
| Imicryl Dis Malzemeleri Sanayi VE Ticaret AS | Türkiye | Maker | Calciplus LC, Calciplus RL, Calciplus, Imical, Biofactor MTA, Therra, Cavitimi | 5 | 2022 |
| Shenzhen Rogin Medical Co., Ltd. | China | Maker | Niti Spreader, Niti Plugger · Stainless Steel Spreaders/Pluggers, Gutta Percha Pluggers | 1 | 2025 |
| DentalMaster (Xiamen) Medical Technology Co., Ltd. | China | Maker | PTFE Tape | 1 | 2026 |
| Shenzhen Superline Technology Co Ltd | China | Maker | Deltajet · Fliex · NIC · ROOT.X · +2 | 1 | 2025 |
| Hu-Friedy Mfg Co., LLC | United States | Maker | Hu-Friedy Mfg Co.,LLC · PULP CANAL FILLING MATERIAL | 8 | 2012 |
| Integra LifeSciences Corporation | United States | Maker | Miltex · Onyx-Flex · Onyx-H · Onyx-R · +1 | 2 | 2014 |
| Storz AM Mark GmbH | Germany | Maker | Spreader | 2 | 2008 |
| B&L Biotech Co., Ltd. | South Korea | Maker | Alpha II Spreader SPRDN · Alpha II Spreader SPRDS · Obtura Spartan Narrow Spreader · Obtura Spartan Standard Spreader | 1 | 2006 |
| Directa AB | Sweden | Maker | Finger Spreader · NiTi Spreader | 1 | 2015 |
| Gebr. Brasseler GmbH & Co. KG | Germany | Maker | KOMET ROOT CANAL SPREADER, NERVE BROACHES | 1 | 2007 |
| BioMTA | South Korea | Maker | OrthoMTA Carrier | 1 | 2014 |
| Osung Mnd Co Ltd | South Korea | Maker | SR1S · SRMA57 | — | — |
| ErgoDenta ApS | Denmark | Maker | Endo Spreader 0.4mm & Plugger 0.4mm · Endo Spreader 0.4mm & Plugger 0.6mm · Endo Spreader 0.6mm & Plugger 0.8mm · Endo Spreader 0.6mm & Plugger 1mm · +7 | — | — |
| Endoperfection Ltd | United Kingdom | Maker | Finger Spreaders (NiTi), 15, 21 · Finger Spreaders (NiTi), 15, 25 · Finger Spreaders (NiTi), 20, 21 · Finger Spreaders (NiTi), 20, 25 · +20 | — | — |
| Schobell Industrial Ltda | Brazil | Maker | Endodontic Spatula WEST 3/4 | — | — |
| Shanghai Kangqiao Dental Instruments Factory | China | Maker | Spreaders KRCP S20/S25/S30/S40/S50/S60 (5.5mm round handle) | — | — |
| Debo Medical Technology (Shijiazhuang) Co., Ltd. | China | Maker | Endodontic Root Canal Plug | — | — |
| Shenzhen Denco Medical Co Ltd | China | Maker | Stainless Steel Spreaders/Pluggers, Gutta Percha Pluggers, NiTi Spreaders; NiTi Pluggers | — | — |
| Aspen Surgical Products | United States | Maker | Symmetry Surgical | — | — |
| Technimen Skillers | Pakistan | Maker | FINGER SPREADER · SPREADER | — | — |
| Cislak Manufacturing, Inc. | United States | Maker | Cislak · Zoll Dental | — | — |
| Falcon Surgical Co. (Pvt.) Ltd. | Pakistan | Maker | SPREADER, PULP CANAL FILLING MATERIAL, ENDODONTIC | — | — |
| FKG Dentaire Sarl | Switzerland | Maker | FINGER SPREADERS · FKG · SPREADERS | — | — |
| Medcave Private Limited | Pakistan | Maker | Endodontic Spreader | — | — |
| Nordent MFG., Inc. | United States | Maker | Nordent Spreaders | — | — |
| Lacigrus International | Pakistan | Maker | SPREADER, PULP CANAL FILLING MATERIAL, ENDODONTIC | — | — |
| Comfort Surgical Instruments | Pakistan | Maker | Root canal spreader | — | — |
| Aesculap AG | Germany | Maker | Aesculap | — | — |
| PDT Inc. | United States | Maker | PDT, Inc. | — | — |
| Adolf Schweick Hardt GmbH & Co | Germany | Maker | ROOT CANAL SPREADER | — | — |
| Confident Instruments | Pakistan | Maker | Artman Instruments | — | — |
| Mani, Inc. (Head Office) | Japan | Maker | FINGER SPREADER · MANI FLARE SPREADERS · MANI SPREADERS · SPREADER | — | — |
| ZOGEAR Medical Co., Ltd. | China | Maker | SPREADER, PULP CANAL FILLING MATERIAL, ENDODONTIC | — | — |
| Hilbro Instruments (Pvt) Ltd | Pakistan | Maker | SPREADER, PULP CANAL FILLING MATERIAL, ENDODONTIC | — | — |
| Medisporex Private Limited | Pakistan | Maker | MEDIS | — | — |
| Dentag SRL | Italy | Maker | DENTAG | — | — |
| Shenzhen Forever Medical Devices Co., Ltd | China | Maker | M:1# · M:2# · M:3# · M:4# · +1 | — | — |
| Acheron Instruments (Pvt.) Ltd. | Pakistan | Maker | Spreaders | — | — |
| Innovative Material And Devices, Inc. | China | Maker | NiTi Spreaders, Stainless Steel Pluggers, Dental Post, Absorbent Paper Points, Pulp Canal Filling Material, Endodontic | — | — |
| Huizhou Videya Technology Co., Ltd. | China | Maker | VIDEYA, Dental Paste Carriers | — | — |
| Biopsy Fine Cut Instruments | Pakistan | Maker | FILLING INSTRUMENT · SPREADER, PULP CANAL FILLING MATERIAL, ENDODONTIC | — | — |
| Acme Commercial Ways Ltd. | Pakistan | Maker | SPREADER, PULP CANAL FILLING MATERIAL, ENDODONTIC | — | — |
| Daddy D Pro | Pakistan | Maker | Spreader Pulp Canal, Filling Material Endodontic | — | — |
| Nopa Instruments Medizintechnik GmbH | Germany | Maker | SPREADER | — | — |
| Surjex | Pakistan | Maker | SPREADER, PULP CANAL FILLING MATERIAL, ENDODONTIC | — | — |
| Pilotis Tech LLC | United States | Maker | Intrace USA | — | — |
| Henan Lusterdent Medical Instrument Co.,Ltd | China | Maker | Endodontic Stainless Steel Spreaders / Pluggers | — | — |
| Meed Skills Surgical | Pakistan | Maker | Meed Skills Surgical | — | — |
| CDM Center of Excellence Ltd. | China | Maker | Spreader, Pulp Canal Filling Material, Endodontic | — | — |
| Gavin Biotechnology Co.,ltd | China | Maker | Endodontic sealer · root canal gap-filling sealant · root canal gap-sealing paste · root canal sealer · +2 | — | — |
| S.R.R. Surgical Co | Pakistan | Maker | Rib Spreaders | — | — |
| Alvi Expo | Pakistan | Maker | SPREADER, PULP CANAL FILLING MATERIAL, ENDODONTIC | — | — |
| Nawaz and Sons | Pakistan | Maker | EKK / SPREADER, PULP CANAL FILLING MATERIAL, ENDODONTIC | — | — |
| SKY DENT Corp for dental trading | United States | Maker | SKY DENT SPREADER - 1DERFUL SPREADER | — | — |
| Win Wings Corp. | Pakistan | Maker | SPREADER, PULP CANAL FILLING MATERIAL, ENDODONTIC | — | — |
| Mts Brothers Surgical Instruments | Pakistan | Maker | Finochietto Rib Spreader Adult, Fixed Blade 70mm x 65mm, Overall Width 240mm | — | — |
| Power Dental USA | United States | Maker | — | — | — |
| J C India | India | Maker | Rainbow Bio CER · Rainbow CAL · Rainbow CAL I, · Rainbow MTA Putty | — | — |
| Peter Brasseler Holdings, LLC | United States | Maker | — | — | — |
| Shanghai Toboom Dental Techology CO., LTD. | China | Maker | SPREADER, PULP CANAL FILING MATERIAL, ENDODONTIC | — | — |
| FFDM Tivoly | France | Maker | Lenhlo · Paste Filler TS · Spreader, Pulp Canal Filling Material | — | — |
| USTOMED INSTRUMENTE GmbH & Co. KG | Germany | Maker | — | — | — |
| Helmut Zepf Medizintechnik GmbH | Germany | Maker | — | — | — |
| Pac-Dent Inc. | United States | Contract manufacturer | FINGER SPREADER · G-FILE METAL · JS Dental · LENTULO PSTE FILL · +1 | 5 | 2022 |
| Wuxi Lyusmile Imp and Exp Co.,ltd | China | Private-label distributor | ENDO FILE · SPREADER FILE | — | — |
| Dentimed Sao Joao LLC | United States | Repacker / relabeler | Angelus | — | — |
| TitanLinks Logistics LLC | United States | Repacker / relabeler | endo spreader | — | — |
| Jmu Dental, Inc. | United States | Repacker / relabeler | Gutta Percha Pluggers | — | — |
| Soher Med Limited | Hong Kong SAR China | Foreign exporter | endo spreader | — | — |
| Shanghai Fanta Dental Materials Co., Ltd. | China | Foreign exporter | — | — | — |
| Shanghai smedent medical instrument co., ltd. | China | Foreign exporter | Starryshine | — | — |
| Sterlab | France | Contract sterilizer | FINGER SPREADER | — | — |
| E/T Endodontic Technologies, Ltd. | Canada | Foreign exporter | MANI Finger Spreaders | — | — |
| Cambrian Medical, Inc. | United States | Repacker / relabeler | cambrian medical | — | — |
| 3D Dental Designs and Development LLC | United States | Contract manufacturer | — | — | — |
| Mainline Medical Dental Supply | Canada | Foreign exporter | — | — | — |
| Oketz Logistics LLC | United States | Repacker / relabeler | — | — | — |
510(k) clearances
| Decided | 510(k) | Device | Applicant |
|---|---|---|---|
| 16 Oct 1985 | K853183 | ENDODONTIC ELECTRONIC SPREADER HEATER | Sturgeon Engineering Co. |
Official records: FDA product classification for EKK · 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