A metallic or polymeric based point or cone suitable for use in the obturation of the dental root-canal, but not for support of a coronal restoration.
| Company | Devices | Share |
|---|---|---|
| Coltène/Whaledent Gmbh + Co. Kg | 74 | 50% |
| Henry Schein, Inc. | 42 | 28% |
| The Atlanta Dental Supply Company | 29 | 20% |
| Essential Dental Systems, Inc. | 3 | 2% |
Company = labeler of record on GUDID. 4 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 | 75 |
| EKM | Gutta-Percha | 74 |
| EJK | Liner, Cavity, Calcium Hydroxide | 15 |
| DZN | INSTRUMENTS, DENTAL HAND | 2 |
Use these as the dimensions to specify in a tender line.
148 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Root canal obturating point", from 4 companies. The largest labeler is Coltène/Whaledent Gmbh + Co. Kg with 50% of records.
EKM (GUTTA-PERCHA), EKM (Gutta-Percha), EJK (Liner, Cavity, Calcium Hydroxide), DZN (INSTRUMENTS, DENTAL HAND)
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.