A non-sterile, non-aqueous substance intended for professional use as a dental cement (e.g., pulp capping, liner, base) and/or direct dental restorative material whereby the majority of the setting reaction is based on the hardening reaction between calcium hy
| Company | Devices | Share |
|---|---|---|
| Prevest Denpro Limited | 42 | 32% |
| Axiodent Inc. | 28 | 21% |
| Peter Brasseler Holdings, Llc | 11 | 8% |
| D.S.I Dental Solutions Ltd | 10 | 8% |
| Us Endodontics, Llc | 8 | 6% |
| Dentsply International Inc. | 7 | 5% |
| Ultradent Products, Inc. | 4 | 3% |
| Voco Gmbh | 3 | 2% |
| Cynosure, Llc | 3 | 2% |
| Directa Ab | 3 | 2% |
| Darby Dental Supply, Llc | 2 | 2% |
| Pulpdent Corporation | 2 | 2% |
Company = labeler of record on GUDID. 21 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 |
|---|---|---|
| EJK | Liner, Cavity, Calcium Hydroxide | 50 |
| KIF | Resin, Root Canal Filling | 50 |
| KIF | RESIN, ROOT CANAL FILLING | 17 |
| EJK | LINER, CAVITY, CALCIUM HYDROXIDE | 10 |
| EIC | SYRINGE, PERIODONTIC, ENDODONTIC, IRRIGATING | 1 |
| EBF | Material, Tooth Shade, Resin | 1 |
Use these as the dimensions to specify in a tender line.
No closely related category with 50+ devices.
133 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Calcium hydroxide dental cement", from 21 companies. The largest labeler is Prevest Denpro Limited with 32% of records.
EJK (Liner, Cavity, Calcium Hydroxide), KIF (Resin, Root Canal Filling), KIF (RESIN, ROOT CANAL FILLING), EJK (LINER, CAVITY, CALCIUM HYDROXIDE)
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.