A thermoplastic material intended to be used in the dental laboratory to manufacture a patient-worn dental appliance (e.g., denture/denture base, orthodontic retainer, implant bars, crowns/bridges, occlusal splint, mouthguard); it might in addition be intended
| Company | Devices | Share |
|---|---|---|
| Graphenano Dental Sl. | 356 | 13% |
| Thermoplastic Comfort Sys | 289 | 10% |
| Dreve Dentamid Gmbh | 228 | 8% |
| The Myerson Company Limited | 221 | 8% |
| Perflex Ltd | 198 | 7% |
| Sichuan Yaqi Medical Technology Co., Ltd. | 186 | 7% |
| Global Dental Science Llc | 176 | 6% |
| Erkodent Erich Kopp Gmbh | 166 | 6% |
| Scheu-Dental Gmbh | 162 | 6% |
| Keystone Industries | 156 | 6% |
| Merz Dental Gmbh | 117 | 4% |
| Vertex-Dental B.V. | 99 | 4% |
Company = labeler of record on GUDID. 36 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 |
|---|---|---|
| EBI | Resin, Denture, Relining, Repairing, Rebasing | 1,376 |
| EBG | Crown And Bridge, Temporary, Resin | 513 |
| KMY | POSITIONER, TOOTH, PREFORMED | 489 |
| EBF | Material, Tooth Shade, Resin | 410 |
| KMY | Positioner, Tooth, Preformed | 368 |
| MQC | Mouthguard, Prescription | 281 |
Use these as the dimensions to specify in a tender line.
2,801 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Dental appliance fabrication material, thermoplastic", from 36 companies. The largest labeler is Graphenano Dental Sl. with 13% of records.
EBI (Resin, Denture, Relining, Repairing, Rebasing), EBG (Crown And Bridge, Temporary, Resin), KMY (POSITIONER, TOOTH, 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.