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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
NewTom Giano (2D)
In Commercial Distribution

  • 08033837931416 ()
XGIAN2D

  • Stationary panoramic dental x-ray system, digital
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
X-ray imaging device comprising an X-ray acquisition system, for producing two and three dimensional views for computation and display.
CEFLA SOCIETA' COOPERATIVA
NewTom 5G XL
In Commercial Distribution

  • 08033837931379 ()
P70720008

  • Limited-view-field CT system
X-ray imaging device comprising an X-ray acquisition system, for producing two and three dimensional views for computation and display.
CEFLA SOCIETA' COOPERATIVA
NewTom 5G
In Commercial Distribution

  • 08033837931362 ()
P70720000

  • Limited-view-field CT system
X-ray imaging device comprising an X-ray acquisition system and the control box, for producing two and three dimensional views for computation and display.
CEFLA SOCIETA' COOPERATIVA
NewTom VGi evo
In Commercial Distribution

  • 08033837931348 ()
P70700011

  • Cone beam computed tomography system, head/neck
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 WDS X-POD sensor is intended to capture intraoral digital images when exposed to X-Rays. It includes a color display to allow the user to show the captured X-ray images.
CEFLA SOCIETA' COOPERATIVA
WDS X-POD
In Commercial Distribution

  • 08033837930334 ()
MYXPOD09

  • Dental digital imaging sensor, intraoral
The ZEN-X sensor is intended to capture intraoral digital images when exposed to X-Rays.
CEFLA SOCIETA' COOPERATIVA
ZEN-X
In Commercial Distribution

  • 08033837930327 ()
XZENX17

  • Dental digital imaging sensor, intraoral
Surgical-Osteotomy
SATELEC
TKW4 II TIP N STER
In Commercial Distribution

  • 03609820876443 ()
F87644

  • Hard/soft-tissue ultrasonic surgical system
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