A device made of a combination of metal and tooth-coloured ceramic, and created for a specific post-pubescent/adult patient (custom-made), that functions as an artificial covering to replace the major part, or the whole part, of the clinical crown of a tooth.
| Company | Devices | Share |
|---|---|---|
| Bredent Gmbh & Co. Kg | 208 | 96% |
| Beijing Yingguan Dental Technology Co., Ltd. | 6 | 3% |
| Modern Dental Laboratory (Dg) Co., Ltd. | 3 | 1% |
Company = labeler of record on GUDID. 3 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 |
|---|---|---|
| ELM | Denture, plastic, teeth | 207 |
| NSO | Restoration, Porcelain-Fused-To-Metal | 7 |
| NSJ | Restoration, Noble Metal | 3 |
| NSP | Restoration, Porcelain | 3 |
| EBF | Material, tooth shade, resin | 1 |
Use these as the dimensions to specify in a tender line.
217 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Custom-made dental crown, metal/ceramic", from 3 companies. The largest labeler is Bredent Gmbh & Co. Kg with 96% of records.
ELM (Denture, plastic, teeth), NSO (Restoration, Porcelain-Fused-To-Metal), NSJ (Restoration, Noble Metal), NSP (Restoration, Porcelain)
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.