A non-sterile substance intended for professional use as a dental cement (e.g., luting agent, liner, base) and/or direct dental restorative material whereby the majority of the setting reaction is based on the hardening reaction between an oxide powder [the pr
| Company | Devices | Share |
|---|---|---|
| Harvard Dental International Gmbh | 39 | 35% |
| Henry Schein, Inc. | 20 | 18% |
| Keystone Industries | 19 | 17% |
| Coltène/Whaledent Ag | 10 | 9% |
| Dental Technologies, Inc. | 5 | 4% |
| Dentonics Inc | 5 | 4% |
| Pearson Dental Supplies, Inc. | 4 | 4% |
| Shofu Dental Corporation | 3 | 3% |
| Patterson Dental Supply, Inc. | 3 | 3% |
| Harry J Bosworth Company | 3 | 3% |
| Temrex Corporation | 1 | 1% |
Company = labeler of record on GUDID. 11 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 |
|---|---|---|
| EMA | Cement, Dental | 65 |
| EMA | CEMENT, DENTAL | 44 |
| EMB | Zinc Oxide Eugenol | 1 |
Use these as the dimensions to specify in a tender line.
112 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Zinc phosphate dental cement", from 11 companies. The largest labeler is Harvard Dental International Gmbh with 35% of records.
EMA (Cement, Dental), EMA (CEMENT, DENTAL), EMB (Zinc Oxide Eugenol)
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.