An intraoral device in the form of an envelope or sleeve intended to cover a digital imaging phosphor plate prior to introduction into the oral cavity, to prevent cross-contamination between patients and/or shield the plate from ambient light. This is a single
| Company | Devices | Share |
|---|---|---|
| Palodex Group Oy | 24 | 46% |
| Jmu Dental, Inc | 12 | 23% |
| Unipack Medical Corporation | 7 | 13% |
| The Atlanta Dental Supply Company | 4 | 8% |
| 3D Dental Designs And Development, Llc | 3 | 6% |
| Dürr Dental Se | 2 | 4% |
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 |
|---|---|---|
| PEM | Dental Barriers And Sleeves | 38 |
| NRD | Unit, operative dental, accessories | 11 |
| EGZ | Holder, Film, X-Ray | 3 |
Use these as the dimensions to specify in a tender line.
52 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Dental digital imaging phosphor plate intraoral cover", from 6 companies. The largest labeler is Palodex Group Oy with 46% of records.
PEM (Dental Barriers And Sleeves), NRD (Unit, operative dental, accessories), EGZ (Holder, Film, X-Ray)
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.