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Device Explorer · FDA GUDID · GMDN 16205

Dental x-ray film holder, reusable

A device designed to hold x-ray film while a dental x-ray is being taken and that enables insertion, positioning, stabilization, and removal of the x-ray film for either extraoral or intraoral dental imaging procedures. This is a reusable device.

US‑registered devices737in commercial distribution
Companies21labelers on GUDID
Single‑use6%of device records
Sterile0%labelled sterile
Prescription38%Rx‑only share
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Share of device records

Directa Ab17524%
Dentsply International Inc.13218%
Dental Imaging Technologies Corporation12317%
Cliktech Llc11115%
Sirona Dental, Inc.10715%
Duphamed B.V.304%
Jmu Dental, Inc132%
Metrex Research, Llc122%

Top labelers

CompanyDevicesShare
Directa Ab17524%
Dentsply International Inc.13218%
Dental Imaging Technologies Corporation12317%
Cliktech Llc11115%
Sirona Dental, Inc.10715%
Duphamed B.V.304%
Jmu Dental, Inc132%
Metrex Research, Llc122%
Darby Dental Supply, Llc71%
Dürr Dental Se61%
Plasdent Corporation51%
Steri-Shield Products51%

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

Brand names on the register (sample)

XLinearVisionDC-Air™ Holder PackVistaPosition Anterior/ Posterior KitVistaPosition Anterior/ Posterior Kit TitaniumVistaPosition BitewingVistaPosition EndoVistaPosition PosteriorVistaPosition AnteriorDarby Dental Supply, LLCPlasdentD-Series Size 1.5 Vertical Bitewing DK ORANGE BiD-Series Size 1.5 Horizontal Bitewing DK ORANGE D-Series Size 1.5 Posterior LIME Bite Block 3-PaD-Series Size 1.5 Anterior AQUA Bite Block 3-PacShaRing Universal Sensor Kit Size 2ShaRing Universal Sensor Kit Size 1

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

FDA product codes

CodeNameDevices
EGZHolder, Film, X-Ray495
EGZHolder, film, x-ray126
EHAAligner, beam, x-ray60
EAPUnit, X-Ray, Intraoral48
EHAAligner, Beam, X-Ray44
EHDUnit, X-Ray, Extraoral With Timer38

GMDN & GCC registration

  • GMDN code 16205 · non‑implantable
  • Single‑use 6% · sterile 0% · Rx‑only 38% · OTC 17%
  • 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 dental x-ray film holder, reusable products are registered in the US?

737 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Dental x-ray film holder, reusable", from 21 companies. The largest labeler is Directa Ab with 24% of records.

Which FDA product codes apply?

EGZ (Holder, Film, X-Ray), EGZ (Holder, film, x-ray), EHA (Aligner, beam, x-ray), EAP (Unit, X-Ray, Intraoral)

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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