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 |
|---|---|---|
| Tulsa Dental Products Llc | 819 | 36% |
| Shenzhen Denco Medical Co., Ltd | 326 | 14% |
| 3D Dental Designs And Development, Llc | 267 | 12% |
| Hsg-S Corp. | 181 | 8% |
| Peter Brasseler Holdings, Llc | 175 | 8% |
| Directa Ab | 97 | 4% |
| Us Endodontics, Llc | 81 | 4% |
| The Atlanta Dental Supply Company | 77 | 3% |
| Maillefer Instruments Holding Sàrl | 69 | 3% |
| Jmu Dental, Inc | 53 | 2% |
| Darby Dental Supply, Llc | 37 | 2% |
| Fkg Dentaire Sàrl | 24 | 1% |
Company = labeler of record on GUDID. 19 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 | 1,928 |
| EKS | File, Pulp Canal, Endodontic | 652 |
| EKP | REAMER, PULP CANAL, ENDODONTIC | 280 |
| EIL | GAUGE, DEPTH, INSTRUMENT, DENTAL | 69 |
| EKW | BROACH, ENDODONTIC | 52 |
| EKP | Reamer, Pulp Canal, Endodontic | 17 |
Use these as the dimensions to specify in a tender line.
2,283 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Manual endodontic file/rasp, single-use", from 19 companies. The largest labeler is Tulsa Dental Products Llc with 36% of records.
EKS (FILE, PULP CANAL, ENDODONTIC), EKS (File, Pulp Canal, Endodontic), EKP (REAMER, PULP CANAL, ENDODONTIC), EIL (GAUGE, DEPTH, INSTRUMENT, DENTAL)
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.