Surgical devices · 21 CFR 872 Subpart E
Endodontic Pulp Canal Reamer
FDA device type “Reamer, Pulp Canal, Endodontic”.
- Companies listing it
- 4530 makers
- Brands and models
- 96
- 510(k) clearances
- 60 in five years
- FDA name
- Reamer, Pulp Canal, Endodontic
510(k) clearances per year, 1976–2026
Companies that list EKP
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 |
| Sybron Dental Specialties | United States | Maker | Pulp Canal · Reamers | 203 | 2026 |
| Coltene/Whaledent AG | Switzerland | Maker | K REAMERS · K REAMERS Prime Line · K-Reamers | 45 | 2022 |
| Essential Dental Systems, Inc. | United States | Maker | Safesider HF · SafeSiders | 15 | 2023 |
| Shenzhen Superline Technology Co Ltd | China | Maker | Deltajet · Fliex · NIC · ROOT.X · +2 | 1 | 2025 |
| Integra LifeSciences Corporation | United States | Maker | Integra · Miltex | 2 | 2014 |
| Directa AB | Sweden | Maker | K-reamer | 1 | 2015 |
| Gebr. Brasseler GmbH & Co. KG | Germany | Maker | KOMET ENDODONTIC ROOT CANAL REAMER | 1 | 2007 |
| Abrasive Technology, Inc. | United States | Maker | — | 1 | 1990 |
| Endoperfection Ltd | United Kingdom | Maker | Gates Gliddens, 1-6, 28 · Gates Gliddens, 1-6, 32 · Gates Gliddens, 1, 28 · Gates Gliddens, 1, 32 · +39 | — | — |
| Dentaurum GmbH & Co. KG | Germany | Maker | Reamer | — | — |
| Shenzhen Denco Medical Co Ltd | China | Maker | — | — | — |
| Aspen Surgical Products | United States | Maker | Symmetry Surgical | — | — |
| Falcon Surgical Co. (Pvt.) Ltd. | Pakistan | Maker | REAMER, PULP CANAL, ENDODONTIC | — | — |
| FKG Dentaire Sarl | Switzerland | Maker | BROACHES · EndoSequence Hand Files · FILES · FKG · +5 | — | — |
| Aesculap AG | Germany | Maker | aesculap | — | — |
| Mani, Inc. (Head Office) | Japan | Maker | MANI ENGINE REAMERS · MANI MEDIUM REAMERS · MANI REAMERS | — | — |
| Anqing Clean Dental Instrument Technology Co Ltd | China | Maker | REAMER, PULP CANAL, ENDODONTIC /FILE, PULP CANAL, ENDODONTIC | — | — |
| Innovative Material And Devices, Inc. | China | Maker | Stainless Steel Reamers, NiTi Reamers | — | — |
| Dongguan Wanjin Industrial Co., Ltd | China | Maker | Reamer Endodontic | — | — |
| BUSCH & CO. GmbH & Co. KG | Germany | Maker | REAMER | — | — |
| Jinyuan medical equipment(tianjin)co.,ltd | China | Maker | N/A | — | — |
| SKY DENT Corp for dental trading | United States | Maker | SKY DENT REAMER - 1DERFUL REAMER | — | — |
| Shanghai Toboom Dental Techology CO., LTD. | China | Maker | REAMER, PULP CANAL, ENDODONTIC | — | — |
| FFDM Tivoly | France | Maker | All-Steel Engine Reamer · Hand Reamer | — | — |
| Harald Nordin S.A. | Switzerland | Maker | REAMER | — | — |
| NN Inc Power Solutions | United States | Maker | REAMER, PULP CANAL, ENDODONTIC | — | — |
| Kazan Medical Instruments Plant | Russia | Maker | — | — | — |
| BGSS Company Asia Limited | China | Maker | — | — | — |
| USTOMED INSTRUMENTE GmbH & Co. KG | Germany | Maker | — | — | — |
| Dentimed Sao Joao LLC | United States | Repacker / relabeler | Torino | — | — |
| Patterson Companies, Inc. | United States | Foreign exporter | Patterson Peeso Endodontic drill | — | — |
| STERIS Corporation | United States | Contract sterilizer | — | — | — |
| HSG-S Corp | United States | Manufacturer | — | — | — |
| GoldenDent | United States | Repacker / relabeler | GoldenDent | — | — |
| Shanghai Fanta Dental Materials Co., Ltd. | China | Foreign exporter | — | — | — |
| Shanghai smedent medical instrument co., ltd. | China | Foreign exporter | Starryshine | — | — |
| Toyo Medical Co. | United States | Repacker / relabeler | TOYO MEDICAL CO | — | — |
| Sterlab | France | Contract sterilizer | K-REAMERS | — | — |
| E/T Endodontic Technologies, Ltd. | Canada | Foreign exporter | MANI Reamers | — | — |
| Peter Brasseler Holdings, LLC | United States | Contract manufacturer | Endodontic Hand Files/ Reamer | — | — |
| Diaswiss, S. A. | Switzerland | Manufacturer | REAMER, PULP CANAL, ENDODONTIC | — | — |
| Endo Direct, LLC | United States | Repacker / relabeler | — | — | — |
| Mainline Medical Dental Supply | Canada | Foreign exporter | — | — | — |
| Oketz Logistics LLC | United States | Repacker / relabeler | — | — | — |
510(k) clearances
| Decided | 510(k) | Device | Applicant |
|---|---|---|---|
| 28 Dec 1982 | K823686 | REAMER TYPE K ENDODONTIC | United Dental Mfg., Inc. |
| 28 Sep 1982 | K822620 | ROOT CANAL REAMERS, TYPE K | Union Broach, Div. Moyco Industries, Inc. |
| 19 Feb 1980 | K800291 | ENDEX REAMERS PULP CANAL, ENDODONTIC | Ipco Corp. |
| 20 Apr 1977 | K770331 | DIALYSIS, JET SYSTEM | Janneck Ent. of Texas |
| 5 Apr 1977 | K770598 | ENDODONTIC INSTRUMENTS, R&R CUTWELL | Ransom & Randolph. LLC. |
| 1 Mar 1977 | K770367 | ROOT CANAL FILES & REAMERS | Cemco Tool Co., Inc. |
Official records: FDA product classification for EKP · 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