An assembly of devices that typically consists of a rigid frame, positioning and alignment components, workstation, and a calibrated guide mechanism for precisely positioning probes, other instruments, or implantable devices during dental surgery. The system m
| Company | Devices | Share |
|---|---|---|
| Neocis Inc | 51 | 96% |
| Image Navigation Ltd | 2 | 4% |
Company = labeler of record on GUDID. 2 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 |
|---|---|---|
| PLV | Dental Stereotaxic Instrument | 73 |
| QRY | Dental Navigation System | 10 |
| IWY | Holder, Head, Radiographic | 5 |
| HAW | Neurological Stereotaxic Instrument | 2 |
Use these as the dimensions to specify in a tender line.
53 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Dental stereotactic surgery system", from 2 companies. The largest labeler is Neocis Inc with 96% of records.
PLV (Dental Stereotaxic Instrument), QRY (Dental Navigation System), IWY (Holder, Head, Radiographic), HAW (Neurological Stereotaxic Instrument)
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.