Surgical devices · 21 CFR 872 Subpart E
Root Canal Endodontic Preparer
FDA device type “Preparer, Root Canal Endodontic”.
- Companies listing it
- 4532 makers
- Brands and models
- 107
- 510(k) clearances
- 20 in five years
- FDA name
- Preparer, Root Canal Endodontic
510(k) clearances per year, 1976–2026
Companies that list EKQ
45 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 |
| 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 |
| DiaDent Group International | South Korea | Maker | DiaPrep Pro | 24 | 2026 |
| 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 | MD-ChelCream · MD-Cleanser | 24 | 2024 |
| Premier Dental Products Company | United States | Maker | RC PREP | 28 | 2026 |
| Guilin Kevin Peter Technology Co., Ltd. | China | Maker | EDTA Root Canal Lubricating Gel · EDTA Solution | 3 | 2026 |
| Vericom Co., Ltd. | South Korea | Maker | WELL-PREP ROOT CANAL CLEANSER | 20 | 2026 |
| 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 | 2 | 2024 |
| Coltene/Whaledent AG | Switzerland | Maker | CanalPro EDTA · MM-EDTA CREAM | 45 | 2022 |
| ChangZhou BoMedent Medical Technology Co., Ltd | China | Maker | SCM-019, iBon, iBon Mini, iBon Mini-SE | 2 | 2022 |
| Pulpdent Corporation | United States | Maker | Root Canal Discs · Root Canal Spreader Dryer | 107 | 2021 |
| Prime Dental Manufacturing, Inc. | United States | Maker | Prime-Dent Root Canal Filling Material · RC-CREAM | 9 | 2012 |
| Medical Products Laboratories, Inc. | United States | Maker | — | 2 | 2004 |
| B&L Biotech Co., Ltd. | South Korea | Maker | B&L Paper Point | 1 | 2006 |
| Guilin Yikeshi Medical Instrument Co Ltd | China | Maker | xp-37 · xp-39 · xp-E10D · xp-E11 · +41 | — | — |
| Aspen Surgical Products | United States | Maker | Symmetry Surgical | — | — |
| Accompany Surgical | Pakistan | Maker | Root Canal Spreader | — | — |
| Denta Craft Instruments | Pakistan | Maker | Root Canal Spreader | — | — |
| Dentag SRL | Italy | Maker | DENTAG | — | — |
| Huizhou Videya Technology Co., Ltd. | China | Maker | VIDEYA, Root Canal Drills, Model G, P, B1, B2, M | — | — |
| Aadi Med Private Limited | India | Maker | Endo Paste, Endogel-RC, Endo-L | — | — |
| Viarden Lab LLC | United States | Maker | ENDOPREP, ENDOPREP PLUS, DENCAVI, EDTA 17%, VIARZONI-T, FORMOCRESOL | — | — |
| Shandong Hengfeng Kerui Medical Equipment Co., Ltd | China | Maker | EDTA Root Canal Lubrication Gel | — | — |
| BUSCH & CO. GmbH & Co. KG | Germany | Maker | ROOT CANAL DRILLS | — | — |
| Hantech Medical Device Co., Ltd. | China | Maker | EndoActivator Tips | — | — |
| J&J Instruments | United States | Maker | — | — | — |
| Foshan ORECK Medical Technology Co.,Ltd | China | Maker | Root canal enlarger (Gates drills, Pesso reamers, Fiber post drills) | — | — |
| I-Dent Innovations for Dentistry SA | Switzerland | Maker | — | — | — |
| Sybron Dental Specialties | United States | Contract manufacturer | SmearClear Mix | 203 | 2026 |
| DSI Dental Solutions Ltd | Israel | Manufacturer | DSI ApexCream EDTA RC Preparation Cream | 2 | 2025 |
| Engineered Endodontics | United States | Repacker / relabeler | — | 1 | 2019 |
| Jersey Dental Supplies | United States | Repacker / relabeler | PREPARER, ROOT CANAL ENDODONTIC | — | — |
| Dentimed Sao Joao LLC | United States | Repacker / relabeler | Torino | — | — |
| Ortho Pro Dent LLC | United States | Repacker / relabeler | Defon- Gel · RC-CREAM · Root Canal Filling Material | — | — |
| Diadent Group Intl., Inc. | Canada | Foreign exporter | DiaPrep Pro | — | — |
| LLD Care d.o.o. | Croatia | Foreign exporter | RC-Prep | — | — |
| Meta Dental Corp. | United States | Repacker / relabeler | MD Cleanser | — | — |
| E/T Endodontic Technologies, Ltd. | Canada | Foreign exporter | CHELATE | — | — |
| Sure Dent Corporation | South Korea | Manufacturer | Sure-Prep | — | — |
| Mainline Medical Dental Supply | Canada | Foreign exporter | — | — | — |
| Oketz Logistics LLC | United States | Repacker / relabeler | — | — | — |
510(k) clearances
| Decided | 510(k) | Device | Applicant |
|---|---|---|---|
| 4 Oct 1983 | K832378 | VIBRATORY ENDODONTIC SYSTEM | Syntex Dental Products, Inc. |
| 21 Jul 1980 | K801463 | OJ-1 ENDODONIC ROOT CANAL FILE HOLDER | Almore Intl., Inc. |
Official records: FDA product classification for EKQ · 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