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Device Explorer · FDA GUDID · GMDN 45256

Digital imaging cassette/storage phosphor screen, dental

A combination device for dental applications that consists of a cassette (barrier envelope) used to hold and shield an attached phosphor storage screen [mounted on a phosphor storage plate (PSP)] from exposure to room light during transport and insertion into

US‑registered devices70in commercial distribution
Companies11labelers on GUDID
Single‑use60%of device records
Sterile1%labelled sterile
Prescription9%Rx‑only share
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Share of device records

Air Techniques, Inc.2536%
3D Dental Designs And Development, Llc2029%
Young Mydent, Llc69%
Amd Medicom Inc34%
Young Innovations, Inc.34%
Group Practice Solutions Inc.34%
Bgss Company Inc.34%
Benco Dental Supply Co.34%

Top labelers

CompanyDevicesShare
Air Techniques, Inc.2536%
3D Dental Designs And Development, Llc2029%
Young Mydent, Llc69%
Amd Medicom Inc34%
Young Innovations, Inc.34%
Group Practice Solutions Inc.34%
Bgss Company Inc.34%
Benco Dental Supply Co.34%
Owandy Radiology23%
Dental Health Products Inc11%
Stradis Medical, Llc11%

Company = labeler of record on GUDID. 11 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

Owandy RadiologyElements by Hedy Barrier EnvelopesDefendHealth-Tec/DHP PSP Barrier EnvelopesGPSVisionary by 3D DentalSAFE DENTScanX Barrier EnvelopesPhosphor Storage PlateBENCOStradis Medical, LLC.

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

FDA product codes

CodeNameDevices
PEMDental Barriers And Sleeves16
EAMScreen, Intensifying, Radiographic13
IWZFilm, Radiographic12
IXCIlluminator, Radiographic-Film9
EGZHolder, Film, X-Ray7
MUHSystem,X-Ray,Extraoral Source,Digital5

GMDN & GCC registration

  • GMDN code 45256 · non‑implantable
  • Single‑use 60% · sterile 1% · Rx‑only 9% · OTC 4%
  • 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.

No closely related category with 50+ devices.

How many digital imaging cassette/storage phosphor screen, dental products are registered in the US?

70 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Digital imaging cassette/storage phosphor screen, dental", from 11 companies. The largest labeler is Air Techniques, Inc. with 36% of records.

Which FDA product codes apply?

PEM (Dental Barriers And Sleeves), EAM (Screen, Intensifying, Radiographic), IWZ (Film, Radiographic), IXC (Illuminator, Radiographic-Film)

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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