Surgical devices · 21 CFR 872 Subpart E
Endodontic Broach
FDA device type “Broach, Endodontic”.
- Companies listing it
- 3321 makers
- Brands and models
- 55
- 510(k) clearances
- 70 in five years
- FDA name
- Broach, Endodontic
510(k) clearances per year, 1976–2026
Companies that list EKW
33 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 | Barbed Broaches | 24 | 2026 |
| Coltene/Whaledent AG | Switzerland | Maker | NERVE BROACHES | 45 | 2022 |
| Shenzhen Rogin Medical Co., Ltd. | China | Maker | Barbed Broaches, Barbed Broaches · Square Broaches | 1 | 2025 |
| Shenzhen Superline Technology Co Ltd | China | Maker | Deltajet · Fliex · NIC · ROOT.X · +2 | 1 | 2025 |
| Directa AB | Sweden | Maker | Barb Broaches | 1 | 2015 |
| Endoperfection Ltd | United Kingdom | Maker | Barbed Broach, 0-6, 21 · Barbed Broach, 0-6, 25 · Barbed Broach, 0, 21 · Barbed Broach, 0, 25 · +14 | — | — |
| B. Ali Impex | Pakistan | Maker | BALI · DOCTOR NICE | — | — |
| Shenzhen Denco Medical Co Ltd | China | Maker | Barbed Broaches · Square Broaches | — | — |
| Aspen Surgical Products | United States | Maker | Symmetry Surgical | — | — |
| Pomee Corporation | Pakistan | Maker | Endodontic Explorers · Endodontic Instruments · Root Canal Spreaders · Stieglitz Fragment Forceps | — | — |
| FKG Dentaire Sarl | Switzerland | Maker | BARBED BROACHES | — | — |
| Mani, Inc. (Head Office) | Japan | Maker | MANI SHORT BARBED BROACHES | — | — |
| Huizhou Videya Technology Co., Ltd. | China | Maker | VIDEYA, Barbed Broaches | — | — |
| Henan Lusterdent Medical Instrument Co.,Ltd | China | Maker | Endodontic Barbed Broaches | — | — |
| CDM Center of Excellence Ltd. | China | Maker | Broach, Endodontic | — | — |
| SKY DENT Corp for dental trading | United States | Maker | SKY DENT NERVE BROACH - 1DERFUL NERVE BROACH | — | — |
| Dongguan Integrity Medical Instrument Co.,Ltd. | China | Maker | Barbed Broach (Nerve Broach) Length: 21mm/25mm Model: 0#,1#, 2#, 3#, 4#, 5#, 6#, 0-6# | — | — |
| Peter Brasseler Holdings, LLC | United States | Maker | — | — | — |
| Shanghai Toboom Dental Techology CO., LTD. | China | Maker | BROACH, ENDONDONTIC | — | — |
| Kazan Medical Instruments Plant | Russia | Maker | Barbed broaches short L-30 mm | — | — |
| Integra LifeSciences Corporation | United States | Contract manufacturer | Miltex | 2 | 2014 |
| Dentimed Sao Joao LLC | United States | Repacker / relabeler | Torino | — | — |
| STERIS Corporation | United States | Contract sterilizer | — | — | — |
| HSG-S Corp | United States | Manufacturer | EdgeBroaches · EdgeEndo | — | — |
| Diadent Group Intl., Inc. | Canada | Foreign exporter | Barbed Broaches | — | — |
| Shanghai Fanta Dental Materials Co., Ltd. | China | Foreign exporter | — | — | — |
| Shanghai smedent medical instrument co., ltd. | China | Foreign exporter | Starryshine | — | — |
| E/T Endodontic Technologies, Ltd. | Canada | Foreign exporter | ANTAEOS BARBED BROACHES | — | — |
| Diaswiss, S. A. | Switzerland | Manufacturer | EKW / BROACH, ENDODONTIC | — | — |
| 3D Dental Designs and Development LLC | United States | Contract manufacturer | — | — | — |
| Bright Supply Inc | United States | Lister | — | — | — |
| Oketz Logistics LLC | United States | Repacker / relabeler | — | — | — |
510(k) clearances
| Decided | 510(k) | Device | Applicant |
|---|---|---|---|
| 24 Jun 1987 | K871493 | DENTI-TRAY(TM) | Advanced Medical, Inc. |
| 27 May 1987 | K870765 | CANNULATED INSTRUMENT CLEANERS | Treace Medical, Inc. |
| 1 Aug 1986 | K862523 | MAN SURG INSTR/ACCESS DUMBACH TITAN MESH IMPL SYS | Walter Lorenz Surgical, Inc. |
| 12 Jul 1983 | K831749 | ENDODONTIC BROACH(76EKN) BARBED BROACH | Union Branch |
| 15 Dec 1982 | K823489 | ENDODONTIC BROACH-BARBED BROACH | Union Broach, Div. Moyco Industries, Inc. |
| 19 Feb 1980 | K800292 | ENDEX BROACH, ENDODONTIC | Ipco Corp. |
| 15 Nov 1976 | K760985 | HAND INSTRUMENTS | Adp Intl., Inc. |
Official records: FDA product classification for EKW · 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