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Device Explorer · FDA GUDID · GMDN 44245

Stationary panoramic/tomographic dental x-ray system, digital

A diagnostic digital dental x-ray system designed for permanent fixture in one location with an extraoral x-ray sensor and source intended to generate and control x-ray beams used in advanced dental imaging applications involving the teeth, jaw, oral cavity, s

US‑registered devices346in commercial distribution
Companies22labelers on GUDID
Single‑use3%of device records
Sterile0%labelled sterile
Prescription54%Rx‑only share
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Share of device records

Ray Co., Ltd10631%
Vatech Co., Ltd.4312%
Sirona Dental Systems Gmbh4012%
De Götzen Srl268%
Cefla Societa' Cooperativa195%
Midmark Corporation175%
Genoray Co., Ltd.165%
Hdx Will Corp.113%

Top labelers

CompanyDevicesShare
Ray Co., Ltd10631%
Vatech Co., Ltd.4312%
Sirona Dental Systems Gmbh4012%
De Götzen Srl268%
Cefla Societa' Cooperativa195%
Midmark Corporation175%
Genoray Co., Ltd.165%
Hdx Will Corp.113%
Planmeca Oy103%
Yoshida Dental Mfg. Co., Ltd., The103%
J.Morita Mfg.Corp.93%
Dentium Co., Ltd93%

Company = labeler of record on GUDID. 22 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

EighteethMeyerDental Cone-beam Computed TomographyScanora 6Cliniview 11Planmeca VisoPlanmeca ProMaxi-DixelVeraview X800VeraviewepocsVeraviewepocs 3D R100Veraviewepocs 3D F40Panoura X-ERAImageWorks PanouraStellaris 3D CephStellaris 3D

Sample of brand names as labelled; no endorsement. Ask us for the full list with company, model and UDI.

FDA product codes

CodeNameDevices
OASX-Ray, Tomography, Computed, Dental307
MUHSystem,X-Ray,Extraoral Source,Digital111
MUHSystem, X-Ray, Extraoral Source, Digital45
OASX-ray, tomography, computed, dental19
MUHSystem, x-ray, extraoral source, digital17
EHDUnit, X-Ray, Extraoral With Timer5

GMDN & GCC registration

  • GMDN code 44245 · non‑implantable
  • Single‑use 3% · sterile 0% · Rx‑only 54% · OTC 5%
  • UAE: MOHAP / DoH medical device registration and an authorised representative are required; Saudi: SFDA MDMA. We check status on request.

Size attributes recorded

No structured size data on the register.

Use these as the dimensions to specify in a tender line.

How many stationary panoramic/tomographic dental x-ray system, digital products are registered in the US?

346 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Stationary panoramic/tomographic dental x-ray system, digital", from 22 companies. The largest labeler is Ray Co., Ltd with 31% of records.

Which FDA product codes apply?

OAS (X-Ray, Tomography, Computed, Dental), MUH (System,X-Ray,Extraoral Source,Digital), MUH (System, X-Ray, Extraoral Source, Digital), OAS (X-ray, tomography, computed, dental)

Is this the same as UAE/GCC registration?

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.

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