A substance intended for professional use as a dental cement (e.g., luting agent, liner, base, pulp-capping material, root canal sealer) and/or direct dental restorative material whereby the majority of the setting reaction is based on the hardening reaction o
| Company | Devices | Share |
|---|---|---|
| Nusmile, Ltd. | 53 | 27% |
| Enpunuo Biotechnology Co., Ltd | 22 | 11% |
| Ormco Corporation | 13 | 7% |
| Beijing C-Root Dental Medical Devices Co., Ltd. | 10 | 5% |
| Peter Brasseler Holdings, Llc | 10 | 5% |
| Essential Dental Systems, Inc. | 9 | 5% |
| Angelus Industria De Produtos Odontologicos S A | 9 | 5% |
| Harvard Dental International Gmbh | 6 | 3% |
| Septodont Sas Specialites Septodont | 6 | 3% |
| Maruchi | 6 | 3% |
| Shiva Products | 5 | 3% |
| Mediclus Co.,Ltd | 5 | 3% |
Company = labeler of record on GUDID. 30 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 |
|---|---|---|
| KIF | Resin, Root Canal Filling | 126 |
| KIF | RESIN, ROOT CANAL FILLING | 43 |
| EMA | CEMENT, DENTAL | 11 |
| EMA | Cement, Dental | 4 |
| EJK | Liner, Cavity, Calcium Hydroxide | 2 |
| EKM | Gutta-Percha | 2 |
Use these as the dimensions to specify in a tender line.
No closely related category with 50+ devices.
197 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Hygroscopic dental cement", from 30 companies. The largest labeler is Nusmile, Ltd. with 27% of records.
KIF (Resin, Root Canal Filling), KIF (RESIN, ROOT CANAL FILLING), EMA (CEMENT, DENTAL), EMA (Cement, 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.