A collection of various sterile dental/surgical instruments, dressings and the necessary materials intended to be used to perform a dental or oral/maxillofacial surgical procedure. It does not contain any pharmaceuticals. This is a single-use device.
| Company | Devices | Share |
|---|---|---|
| Cardinal Health 200, Llc | 739 | 88% |
| Institut Straumann Ag | 30 | 4% |
| Aligned Medical Solutions | 24 | 3% |
| Dermapac Inc. | 12 | 1% |
| Dentsply Implants Manufacturing Gmbh | 9 | 1% |
| Robinson Healthcare Limited | 9 | 1% |
| Thommen Medical Ag | 6 | 1% |
| Zest Anchors, Llc | 4 | 0% |
| Suzhou Juneland Medical Co., Ltd. | 3 | 0% |
| Osteogenics Biomedical Inc | 1 | 0% |
| Bound Tree Medical, Llc | 1 | 0% |
| Tt Tooth Transformer Srl | 1 | 0% |
Company = labeler of record on GUDID. 12 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 |
|---|---|---|
| OFX | General purpose dental tray | 674 |
| OFX | General purpose dental tray (kit) | 49 |
| NDP | Accessories, implant, dental, endosseous | 47 |
| OFX | General Purpose Dental Tray | 14 |
| OFW | Restorative instrument and component tray | 12 |
| PWL | Oral Surgery Tray | 10 |
Use these as the dimensions to specify in a tender line.
839 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Dental/maxillofacial surgical procedure kit, non-medicated, single-use", from 12 companies. The largest labeler is Cardinal Health 200, Llc with 88% of records.
OFX (General purpose dental tray), OFX (General purpose dental tray (kit)), NDP (Accessories, implant, dental, endosseous), OFX (General Purpose Dental Tray)
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.