A device made totally of ceramic material, 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 |
|---|---|---|
| Osstem Implant Co.,Ltd. | 1,110 | 97% |
| Institut Straumann Ag | 22 | 2% |
| Beijing Yingguan Dental Technology Co., Ltd. | 4 | 0% |
| Modern Dental Laboratory (Dg) Co., Ltd. | 3 | 0% |
| Aceso Dental Laboratory Company Limited | 2 | 0% |
| Shenzhen Jiahong Dental Technology Co.,Ltd. | 1 | 0% |
Company = labeler of record on GUDID. 6 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 |
|---|---|---|
| EIH | Powder, Porcelain | 1,317 |
| EIH | POWDER, PORCELAIN | 38 |
| NSP | Restoration, Porcelain | 9 |
| NSQ | Restoration, Base Metal | 2 |
| ELL | Teeth, Porcelain | 1 |
| NSR | Prosthesis, Orthodontic | 1 |
Use these as the dimensions to specify in a tender line.
1,142 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Custom-made dental crown, ceramic", from 6 companies. The largest labeler is Osstem Implant Co.,Ltd. with 97% of records.
EIH (Powder, Porcelain), EIH (POWDER, PORCELAIN), NSP (Restoration, Porcelain), NSQ (Restoration, Base Metal)
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.