Consulting Wallah › Device Explorer › Dental › Dental x-ray film, non-screen
Device Explorer · FDA GUDID · GMDN 40978

Dental x-ray film, non-screen

A non-screen x-ray film specifically sized and designed for use with dental x-ray systems. It is designed for direct exposure to x-rays and is relatively insensitive to the visible light emitted from screens. It is prepared as an emulsion of light and x-ray se

US‑registered devices184in commercial distribution
Companies10labelers on GUDID
Single‑use95%of device records
Sterile0%labelled sterile
Prescription3%Rx‑only share
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Share of device records

Flow X Ray Corporation9853%
Carestream Health, Inc.3117%
Henry Schein, Inc.127%
Darby Dental Supply, Llc95%
Young Innovations, Inc.84%
National Distribution & Contracting, Inc.63%
Benco Dental Supply Co.63%
Agfa53%

Top labelers

CompanyDevicesShare
Flow X Ray Corporation9853%
Carestream Health, Inc.3117%
Henry Schein, Inc.127%
Darby Dental Supply, Llc95%
Young Innovations, Inc.84%
National Distribution & Contracting, Inc.63%
Benco Dental Supply Co.63%
Agfa53%
3D Dental Designs And Development, Llc53%
Safco Dental Supply Co.42%

Company = labeler of record on GUDID. 10 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

Dentus M2 ComfortDentus E-SpeedDarby Dental Supply, LLCThe Orthodontic StoreSafco X-Pose intraoral x-ray filmVisionary by 3D DentalMaxi-Dent D Speed VinylMaxi-Dent D Speed Vinyl, ChildPatterson DentalMinimax TRX-SMinimax TRX-0Minimax Bitewing TRX-3FV-58 ADULT 50/BOX FRESH PAKDV-58 ADULT 50/BOX FRESH PAKFV-53 CHILD TWIN PEDO PAKFV-54 CHILD PEDO PAK

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

FDA product codes

CodeNameDevices
IWZFilm, Radiographic140
IWZFilm, radiographic74
NOFSystem, optical impression, computer assisted design and man1

GMDN & GCC registration

  • GMDN code 40978 · non‑implantable
  • Single‑use 95% · sterile 0% · Rx‑only 3% · 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 (Centimeter) · 5Width (Centimeter) · 5

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

How many dental x-ray film, non-screen products are registered in the US?

184 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Dental x-ray film, non-screen", from 10 companies. The largest labeler is Flow X Ray Corporation with 53% of records.

Which FDA product codes apply?

IWZ (Film, Radiographic), IWZ (Film, radiographic), NOF (System, optical impression, computer assisted design and man)

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.

How do I get quotes?

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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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