Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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Digital panoramic and cephalometric extra­oral X-­ray system.
CEFLA SOCIETA' COOPERATIVA
hyperion X9 (2D)
In Commercial Distribution

  • 08033837931409 ()
X92D015

  • Stationary panoramic dental x-ray system, digital
Extraoral X-ray system for digital panoramic X-rays suitable for production of orthopanoramic images of the maxillofacial region, diagnostic examination of the dentition (teeth), arches and other structures of the oral cavity.
CEFLA SOCIETA' COOPERATIVA
NewTom GO (2D)
In Commercial Distribution

  • 08033837931317 ()
XNEWTGO

  • Stationary panoramic dental x-ray system, digital
Extraoral X-ray system for digital panoramic X-rays suitable for production of orthopanoramic images of the maxillofacial region, diagnostic examination of the dentition (teeth), arches and other structures of the oral cavity.
CEFLA SOCIETA' COOPERATIVA
hyperion X5 (2D)
In Commercial Distribution

  • 08033837930914 ()
XHYPEX5

  • Stationary panoramic dental x-ray system, digital
The DENTIOIII-S is intended for dental radiographic examination of the teeth and temporomandibular joints, specifically for panoramic and cephalometric examinations. It is to be used only by dental practitioners and/or radiologists.
HDX WILL CORP.
DENTIOIII-S
In Commercial Distribution

  • 08800005200120 ()


  • Stationary panoramic dental x-ray system, digital
The DENTIOIII is intended for dental radiographic examination of the teeth and temporomandibular joints, specifically for panoramic examinations. It is to be used only by dental practitioners and/or radiologists.
HDX WILL CORP.
DENTIOIII
In Commercial Distribution

  • 08800005200113 ()


  • Stationary panoramic dental x-ray system, digital
Orthophos E
SIRONA Dental Systems GmbH
6708429
In Commercial Distribution

  • E27667084290 ()


  • Stationary panoramic dental x-ray system, digital
Orthophos E
SIRONA Dental Systems GmbH
6708403
In Commercial Distribution

  • E27667084030 ()


  • Stationary panoramic dental x-ray system, digital
Orthophos E
SIRONA Dental Systems GmbH
6707488
In Commercial Distribution

  • E27667074880 ()


  • Stationary panoramic dental x-ray system, digital
Orthophos E
SIRONA Dental Systems GmbH
6707470
In Commercial Distribution

  • E27667074700 ()


  • Stationary panoramic dental x-ray system, digital
Orthophos E
SIRONA Dental Systems GmbH
6707462
In Commercial Distribution

  • E27667074620 ()


  • Stationary panoramic dental x-ray system, digital
ORTHOPHOS XG 3D ready
SIRONA Dental Systems GmbH
6281252
Not in Commercial Distribution

  • E27662812520 ()


  • Stationary panoramic dental x-ray system, digital
ORTHOPHOS XG 3D ready Ceph
SIRONA Dental Systems GmbH
6281245
Not in Commercial Distribution

  • E27662812450 ()


  • Stationary panoramic dental x-ray system, digital
ORTHOPHOS XG 5 Ceph/ XG 5DS Ceph
SIRONA Dental Systems GmbH
6281237
Not in Commercial Distribution

  • E27662812370 ()


  • Stationary panoramic dental x-ray system, digital
ORTHOPHOS XG 5 / XG 5DS
SIRONA Dental Systems GmbH
6281229
Not in Commercial Distribution

  • E27662812290 ()


  • Stationary panoramic dental x-ray system, digital
ORTHOPHOS XG 3
SIRONA Dental Systems GmbH
6237239
Not in Commercial Distribution

  • E27662372390 ()


  • Stationary panoramic dental x-ray system, digital
ORTHOPHOS XG 3
SIRONA Dental Systems GmbH
6005586
Not in Commercial Distribution

  • E27660055860 ()


  • Stationary panoramic dental x-ray system, digital
ORTHOPHOS XG 5 / XG 5DS
SIRONA Dental Systems GmbH
5993394
Not in Commercial Distribution

  • E27659933940 ()


  • Stationary panoramic dental x-ray system, digital
ORTHOPHOS XG 5 Ceph/XG 5DS Ceph
SIRONA Dental Systems GmbH
5993386
Not in Commercial Distribution

  • E27659933860 ()


  • Stationary panoramic dental x-ray system, digital
ORTHOPHOS XG 3D ready Ceph
SIRONA Dental Systems GmbH
5963868
Not in Commercial Distribution

  • E27659638680 ()


  • Stationary panoramic dental x-ray system, digital
ORTHOPHOS XG 3D ready
SIRONA Dental Systems GmbH
5963850
Not in Commercial Distribution

  • E27659638500 ()


  • Stationary panoramic dental x-ray system, digital
No Description
BLUO ELECTRONICS SRL
8468600008
In Commercial Distribution

  • E3158468600008 ()


  • Stationary panoramic dental x-ray system, digital
No Description
BLUO ELECTRONICS SRL
8468600007
In Commercial Distribution

  • E3158468600007 ()


  • Stationary panoramic dental x-ray system, digital
No Description
BLUO ELECTRONICS SRL
8468463221
In Commercial Distribution

  • E3158468463221 ()
9768263221

  • Stationary panoramic dental x-ray system, digital
No Description
BLUO ELECTRONICS SRL
8468463121
In Commercial Distribution

  • E3158468463121 ()
9768263121

  • Stationary panoramic dental x-ray system, digital
No Description
BLUO ELECTRONICS SRL
8468260320
In Commercial Distribution

  • E3158468260320 ()
9768261020

  • Stationary panoramic dental x-ray system, digital
Digital Panoramic X-Ray Unit, including patient positioning items
BLUO ELECTRONICS SRL
8468200300
In Commercial Distribution

  • E31584682003000 ()


  • Stationary panoramic dental x-ray system, digital
Acteon Imaging Suite software program is an application software for general dental and maxillofacial diagnostic imaging. It controls exam retrieval, display, enhancement, and saving of digital images from various digital imaging systems. It stores and communicates these images within the system or across computer systems at distributed locations.
DE GÖTZEN SRL
ACTEON IMAGING SUITE
In Commercial Distribution

  • D804W09000460 ()
W0900046

  • Panoramic/tomographic dental x-ray system application software
Acteon Imaging Suite software program is an application software for general dental and maxillofacial diagnostic imaging. It controls exam retrieval, display, enhancement, and saving of digital images from various digital imaging systems. It stores and communicates these images within the system or across computer systems at distributed locations. It is distributed on DVD
DE GÖTZEN SRL
ACTEON IMAGING SUITE (DVD):
In Commercial Distribution

  • D8049902630 ()
990263

  • Panoramic/tomographic dental x-ray system application software
Pan and Ceph system with one sensor, export
MIDMARK CORPORATION
V5150C
In Commercial Distribution

  • 00841709102837 ()
V5150C

  • Stationary panoramic dental x-ray system, digital
Pan and ceph system with two sensors, export
MIDMARK CORPORATION
V5100C
In Commercial Distribution

  • 00841709102820 ()
V5100C

  • Stationary panoramic dental x-ray system, digital
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