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Device Explorer · FDA GUDID · GMDN 44905

Dental digital imaging sensor, intraoral

An analogue device that is temporarily placed in a patient's mouth to perform routine diagnostic dental imaging procedures. It uses analogue-to-digital conversion techniques to record the absorption pattern of x-ray beams used in the diagnosis and treatment of

US‑registered devices874in commercial distribution
Companies48labelers on GUDID
Single‑use1%of device records
Sterile0%labelled sterile
Prescription85%Rx‑only share
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Share of device records

Sirona Dental, Inc.38744%
Dentsply International Inc.759%
Midmark Corporation657%
Dental Imaging Technologies Corporation577%
Carestream Health, Inc.344%
Gendex Corp.314%
Rayence Co., Ltd.293%
Carestream Dental Llc283%

Top labelers

CompanyDevicesShare
Sirona Dental, Inc.38744%
Dentsply International Inc.759%
Midmark Corporation657%
Dental Imaging Technologies Corporation577%
Carestream Health, Inc.344%
Gendex Corp.314%
Rayence Co., Ltd.293%
Carestream Dental Llc283%
Iray Group121%
Beyes Dental Canada Inc121%
Denterprise International, Inc.111%
Dexis Llc101%

Company = labeler of record on GUDID. 48 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

TuxedoEighteethXLinearVisionDigital Intraoral X-ray Imaging SystemDigital Wireless Intraoral X-Ray SensorDigital Intraoral X-Ray SensorDBADTEWOODPECKERKaVo GXS-700™ intraoral sensorKaVo GXS-700 Sensor Size 2KaVo GXS-700 Sensor Size 1DEXIS Platinum™ intraoral sensorGendex GXS-700™ intraoral sensorPlanmeca ProSensorDC-Air™ Intraoral Sensor

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

FDA product codes

CodeNameDevices
MQBSolid State X-Ray Imager (Flat Panel/Digital Imager)342
MUHSystem, X-Ray, Extraoral Source, Digital278
MUHSystem,X-Ray,Extraoral Source,Digital261
EHDUnit, X-Ray, Extraoral With Timer223
EAPUnit, X-Ray, Intraoral123
MQBSolid state x-ray imager (flat panel/digital imager)75

GMDN & GCC registration

  • GMDN code 44905 · non‑implantable
  • Single‑use 1% · sterile 0% · Rx‑only 85% · 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

Length (Millimeter) · 16Width (Millimeter) · 16Height (Millimeter) · 12

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

How many dental digital imaging sensor, intraoral products are registered in the US?

874 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Dental digital imaging sensor, intraoral", from 48 companies. The largest labeler is Sirona Dental, Inc. with 44% of records.

Which FDA product codes apply?

MQB (Solid State X-Ray Imager (Flat Panel/Digital Imager)), MUH (System, X-Ray, Extraoral Source, Digital), MUH (System,X-Ray,Extraoral Source,Digital), EHD (Unit, X-Ray, Extraoral With Timer)

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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