An elastomeric, polyether-based material capable of reacting to form a rubber-like substance used to reproduce the structure of a patient's teeth and gums, or other oral anatomy, after being placed on an impression tray and inserted into the mouth. This is a s
| Company | Devices | Share |
|---|---|---|
| Danville Materials, Llc | 80 | 29% |
| 3M Deutschland Gmbh | 77 | 28% |
| Kulzer Gmbh | 48 | 18% |
| Gc America Inc. | 46 | 17% |
| Pearson Dental Supplies, Inc. | 14 | 5% |
| Burkhart Dental Supply Co., The | 9 | 3% |
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 |
|---|---|---|
| ELW | MATERIAL, IMPRESSION | 310 |
| ELW | Material, Impression | 28 |
| EID | SYRINGE, RESTORATIVE AND IMPRESSION MATERIAL | 18 |
| EBH | MATERIAL, IMPRESSION TRAY, RESIN | 3 |
| EFD | AMALGAMATOR, DENTAL, AC-POWERED | 3 |
| MVL | CORD, RETRACTION | 2 |
Use these as the dimensions to specify in a tender line.
274 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Polyether dental impression material", from 6 companies. The largest labeler is Danville Materials, Llc with 29% of records.
ELW (MATERIAL, IMPRESSION), ELW (Material, Impression), EID (SYRINGE, RESTORATIVE AND IMPRESSION MATERIAL), EBH (MATERIAL, IMPRESSION TRAY, 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.