A prefabricated prosthetic device designed to function as a permanent artificial covering to partially or fully replace the damaged crown of a tooth. It is made of ceramic and polymer materials and may require minimal fashioning in situ during restorative work
| Company | Devices | Share |
|---|---|---|
| Rhondium Limited | 88 | 68% |
| Merz Dental Gmbh | 42 | 32% |
Company = labeler of record on GUDID. 2 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 |
|---|---|---|
| EBF | Material, Tooth Shade, Resin | 310 |
| EBH | Material, Impression Tray, Resin | 1 |
Use these as the dimensions to specify in a tender line.
130 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Preformed dental crown, permanent", from 2 companies. The largest labeler is Rhondium Limited with 68% of records.
EBF (Material, Tooth Shade, Resin), EBH (Material, Impression Tray, Resin)
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.