A device made entirely of polymer-based material with or without fibre reinforcement, 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
| Company | Devices | Share |
|---|---|---|
| Polident D.O.O. | 259 | 48% |
| Edelweiss Dentistry Products Gmbh | 152 | 28% |
| Bego Bremer Goldschlägerei Wilh. Herbst Gmbh & Co.Kg | 51 | 9% |
| Hangzhou Shining3D Dental Technology Co., Ltd. | 31 | 6% |
| Voco Gmbh | 30 | 6% |
| Envisiontec Gmbh | 6 | 1% |
| Vericom Co., Ltd. | 3 | 1% |
| Vertex-Dental B.V. | 3 | 1% |
| Institut Straumann Ag | 3 | 1% |
| Beijing Yingguan Dental Technology Co., Ltd. | 2 | 0% |
| Shenzhen Jiahong Dental Technology Co.,Ltd. | 1 | 0% |
| Modern Dental Laboratory (Dg) Co., Ltd. | 1 | 0% |
Company = labeler of record on GUDID. 13 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 | 1,629 |
| EBG | CROWN AND BRIDGE, TEMPORARY, RESIN | 366 |
| ELZ | Crown, Preformed | 152 |
| EBF | Material, Tooth Shade, Resin | 141 |
| EBG | Crown And Bridge, Temporary, Resin | 61 |
| PZY | Additively Manufactured, Preformed, Resin Denture Tooth | 60 |
Use these as the dimensions to specify in a tender line.
543 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Custom-made dental crown, polymer", from 13 companies. The largest labeler is Polident D.O.O. with 48% of records.
ELM (Denture, plastic, teeth), EBG (CROWN AND BRIDGE, TEMPORARY, RESIN), ELZ (Crown, Preformed), EBF (Material, Tooth Shade, 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.