An elastomeric, polysiloxane-based material capable of reacting to form a rubber-like substance suitable 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
| Company | Devices | Share |
|---|---|---|
| Gc America Inc. | 249 | 8% |
| Sherpakorea | 247 | 8% |
| Den-Mat Holdings, Llc | 170 | 5% |
| 3M Deutschland Gmbh | 124 | 4% |
| Dentsply International Inc. | 122 | 4% |
| Darby Dental Supply, Llc | 117 | 4% |
| Henry Schein, Inc. | 117 | 4% |
| Coltène/Whaledent Ag | 114 | 4% |
| Clinician'S Choice Dental Products, Inc. | 113 | 4% |
| Kerr Corporation | 108 | 3% |
| Kettenbach Gmbh & Co. Kg | 80 | 3% |
| Ipb | 80 | 3% |
Company = labeler of record on GUDID. 101 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 | 2,078 |
| ELW | MATERIAL, IMPRESSION | 1,537 |
| EID | SYRINGE, RESTORATIVE AND IMPRESSION MATERIAL | 103 |
| KNW | INSTRUMENT, BIOPSY | 40 |
| EHY | Tray, Impression, Preformed | 22 |
| EIG | Retractor, All Types | 22 |
Use these as the dimensions to specify in a tender line.
3,196 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Silicone dental impression material", from 101 companies. The largest labeler is Gc America Inc. with 8% of records.
ELW (Material, Impression), ELW (MATERIAL, IMPRESSION), EID (SYRINGE, RESTORATIVE AND IMPRESSION MATERIAL), KNW (INSTRUMENT, BIOPSY)
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.