A hand-held manual dental instrument designed for direct warm bonding during an endodontic obturation procedure. It is preloaded (encased) with a resin-based sealing, filling, and core material at its distal working end which is subsequently heated in a dedica
| Company | Devices | Share |
|---|---|---|
| Us Endodontics, Llc | 222 | 35% |
| Maillefer Instruments Holding Sàrl | 155 | 25% |
| Tulsa Dental Products Llc | 104 | 17% |
| Hsg-S Corp. | 53 | 8% |
| Henry Schein, Inc. | 38 | 6% |
| Kerr Corporation | 33 | 5% |
| Scott'S Dental Supply L.L.C. | 14 | 2% |
| Xlent Global Inc | 7 | 1% |
| Jmu Dental, Inc | 1 | 0% |
Company = labeler of record on GUDID. 9 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 |
|---|---|---|
| EKM | GUTTA-PERCHA | 534 |
| EIL | GAUGE, DEPTH, INSTRUMENT, DENTAL | 45 |
| EKM | Gutta-Percha | 41 |
| EKK | SPREADER, PULP CANAL FILLING MATERIAL, ENDODONTIC | 7 |
Use these as the dimensions to specify in a tender line.
627 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Warm-bonded endodontic obturation system obturator", from 9 companies. The largest labeler is Us Endodontics, Llc with 35% of records.
EKM (GUTTA-PERCHA), EIL (GAUGE, DEPTH, INSTRUMENT, DENTAL), EKM (Gutta-Percha), EKK (SPREADER, PULP CANAL FILLING MATERIAL, ENDODONTIC)
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.