Consulting Wallah › Device Explorer › Dental › Stationary intraoral dental x-ray system, digital
Device Explorer · FDA GUDID · GMDN 42297

Stationary intraoral dental x-ray system, digital

A diagnostic dental x-ray system designed for permanent fixture in one location to generate and control x-ray beams. It records the absorption pattern of x-ray beams used for general-purpose, routine, dental radiography examinations involving the diagnosis and

US‑registered devices528in commercial distribution
Companies21labelers on GUDID
Single‑use0%of device records
Sterile0%labelled sterile
Prescription97%Rx‑only share
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Share of device records

Midmark Corporation36870%
De Götzen Srl418%
Cefla Societa' Cooperativa306%
Owandy Radiology183%
Carestream Health, Inc.143%
Skanray Technologies Limited92%
Xzeal Technologies, Inc.61%
Carestream Dental Llc61%

Top labelers

CompanyDevicesShare
Midmark Corporation36870%
De Götzen Srl418%
Cefla Societa' Cooperativa306%
Owandy Radiology183%
Carestream Health, Inc.143%
Skanray Technologies Limited92%
Xzeal Technologies, Inc.61%
Carestream Dental Llc61%
Sota Precision Optics, Inc.51%
Guangzhou Ajax Medical Equipment Co., Ltd.41%
Sirona Dental Systems Gmbh41%
Beyes Dental Canada Inc41%

Company = labeler of record on GUDID. 21 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

ADSGendex eXpert DC™ intraoral x-ray systemFocusPlanmeca IntraIntraOs 70FONA XDCVario DGOwandy-RX DCOwandy-RX PROHELIODENT PlusDURAYXZeal Z70 Wall VETXZeal Z70 WallSOTA Cloud Smart SensorINTRASKAN DCClio Prime

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

FDA product codes

CodeNameDevices
EHDUnit, X-Ray, Extraoral With Timer353
EHDUnit, x-ray, extraoral with timer94
EHDUNIT, X-RAY, EXTRAORAL WITH TIMER80
MUHSystem, X-Ray, Extraoral Source, Digital3
LLZSystem, Image Processing, Radiological3

GMDN & GCC registration

  • GMDN code 42297 · non‑implantable
  • Single‑use 0% · sterile 0% · Rx‑only 97% · OTC 0%
  • 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 intraoral dental x-ray system, digital products are registered in the US?

528 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Stationary intraoral dental x-ray system, digital", from 21 companies. The largest labeler is Midmark Corporation with 70% of records.

Which FDA product codes apply?

EHD (Unit, X-Ray, Extraoral With Timer), EHD (Unit, x-ray, extraoral with timer), EHD (UNIT, X-RAY, EXTRAORAL WITH TIMER), MUH (System, X-Ray, Extraoral Source, Digital)

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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