A collection of customized equipment and supplies intended to be used to apply/polymerize composite resins to fill dental cavities or restore damaged dental tissue. It includes the composite resin, which may be self-, light-, or dual-cured, and additional devi
| Company | Devices | Share |
|---|---|---|
| Edelweiss Dr Ag | 51 | 50% |
| Prismatik Dentalcraft, Inc | 41 | 40% |
| Essential Dental Systems, Inc. | 6 | 6% |
| Reliance Orthodontic Products Inc | 4 | 4% |
Company = labeler of record on GUDID. 4 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 | 54 |
| EBF | MATERIAL, TOOTH SHADE, RESIN | 46 |
| EMA | CEMENT, DENTAL | 2 |
Use these as the dimensions to specify in a tender line.
102 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Custom-made dental composite resin kit", from 4 companies. The largest labeler is Edelweiss Dr Ag with 50% of records.
EBF (Material, Tooth Shade, Resin), EBF (MATERIAL, TOOTH SHADE, RESIN), EMA (CEMENT, DENTAL)
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.