A hand-held manual dental instrument designed to debride and enlarge the root canal and smooth its walls by a cutting or abrasive action when moved in a longitudinal direction. It is made of metal [e.g., stainless steel, nickel-titanium alloy (Nitinol)] and it
| Company | Devices | Share |
|---|---|---|
| Henry Schein, Inc. | 843 | 17% |
| Diadent Group International | 699 | 14% |
| Mani, Inc. | 609 | 12% |
| Tulsa Dental Products Llc | 599 | 12% |
| Diaswiss Sa | 444 | 9% |
| Micro Mega | 347 | 7% |
| Darby Dental Supply, Llc | 329 | 7% |
| Benco Dental Supply Co. | 197 | 4% |
| Edenta Etablissement | 192 | 4% |
| Dental Health Products Inc | 124 | 3% |
| Fkg Dentaire Sàrl | 105 | 2% |
| Prevest Denpro Limited | 76 | 2% |
Company = labeler of record on GUDID. 26 companies in total; top 12 shown. Click headers to sort.
Sample of brand names as labelled; no endorsement. Ask us for the full list with company, model and UDI.
| Code | Name | Devices |
|---|---|---|
| EKS | FILE, PULP CANAL, ENDODONTIC | 2,841 |
| EKS | File, Pulp Canal, Endodontic | 1,488 |
| EKP | REAMER, PULP CANAL, ENDODONTIC | 510 |
| DZA | DRILL, DENTAL, INTRAORAL | 195 |
| EKP | Reamer, Pulp Canal, Endodontic | 166 |
| DZA | Drill, Dental, Intraoral | 67 |
Use these as the dimensions to specify in a tender line.
4,946 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Manual endodontic file/rasp, reusable", from 26 companies. The largest labeler is Henry Schein, Inc. with 17% of records.
EKS (FILE, PULP CANAL, ENDODONTIC), EKS (File, Pulp Canal, Endodontic), EKP (REAMER, PULP CANAL, ENDODONTIC), DZA (DRILL, DENTAL, INTRAORAL)
No. GUDID is the US register. For the UAE (MOHAP/DoH) and Saudi (SFDA/MDMA) a separate registration and a local authorised representative are required; Consulting Wallah can check the status and connect you with registered suppliers.
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Source: FDA AccessGUDID (AccessGUDID full release 2 Nov 2026); counts are device records in commercial distribution grouped by GMDN preferred term; companies are labelers of record. Information only — US listing is not a registration in the UAE or GCC; verify with the regulator. © Consulting Wallah — CC BY‑NC‑ND.