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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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The intraoral scanner is a digital optical scanning device used to obtain digital impressions of hard and soft tissues such as teeth, gums, and mucous membrane by means of oral scanning, for oral restoration and orthodontic treatment of malocclusion. The device is an optical impression system used to record the topographical characteristics of teeth, dental impressions, or stone models for use in the computer-aided design (CAD) and computer-aided manufacturing (CAM) of dental restorative prosthetic devices.
CEFLA SOCIETA' COOPERATIVA
VisioScan WR
In Commercial Distribution

  • 08033837938286 ()
7098N001

  • Intraoral optical scanning system
The intraoral scanner is a digital optical scanning device used to obtain digital impressions of hard and soft tissues such as teeth, gums, and mucous membrane by means of oral scanning, for oral restoration and orthodontic treatment of malocclusion. The device is an optical impression system used to record the topographical characteristics of teeth, dental impressions, or stone models for use in the computer-aided design (CAD) and computer-aided manufacturing (CAM) of dental restorative prosthetic devices.
CEFLA SOCIETA' COOPERATIVA
VisioScan WL
In Commercial Distribution

  • 08033837937142 ()
7098N000

  • Intraoral optical scanning system
Primescan 2
SIRONA Dental Systems GmbH
6831015
In Commercial Distribution

  • E27668310150 ()


  • Intraoral optical scanning system
Single use sleeve Primescan 2 Box
SIRONA Dental Systems GmbH
6818699
In Commercial Distribution

  • E27668127750 ()
  • E27668186992 ()


  • Intraoral optical scanning system
Primescan 2 Multiuse Sleeve
SIRONA Dental Systems GmbH
6805365
In Commercial Distribution

  • E27668053650 ()
6805365

  • Intraoral optical scanning system
Primescan 2
SIRONA Dental Systems GmbH
6802040
In Commercial Distribution

  • E27668020400 ()
6802040

  • Intraoral optical scanning system
Primescan 2 Cart
SIRONA Dental Systems GmbH
6800457
In Commercial Distribution

  • E27668004570 ()
6800457

  • Intraoral optical scanning system
Primescan sleeve stainless steel
SIRONA Dental Systems GmbH
6673672
In Commercial Distribution

  • E27666736720 ()
6673672

  • Intraoral optical scanning system
Primescan 2 Spare
SIRONA Dental Systems GmbH
6835610
In Commercial Distribution

  • E27668356100 ()
6835610

  • Intraoral optical scanning system
Primescan 2
SIRONA Dental Systems GmbH
6802040
Not in Commercial Distribution

  • E2766802040 ()
6802040

  • Intraoral optical scanning system
Primescan sleeve stainless steel Rep
SIRONA Dental Systems GmbH
6777150
In Commercial Distribution

  • E27667771500 ()
6777150

  • Intraoral optical scanning system
Huvitz Dental Intraoral Scanner OCT (LSO-100) is a dental 3D scanner intended to be used to digitally record topographical characteristics of teeth and surrounding tissues. LSO-100 produces 3D scans for use in computer-assisted design and manufacturing of dental restorations.
Huvitz Co., Ltd.
LSO-100
In Commercial Distribution

  • 08800019600961 ()
Y4XXCL-24-00001

  • Intraoral optical scanning system
Lilivis Scan LS-100 (Intraoral Scanner)
Huvitz Co., Ltd.
LS-100
In Commercial Distribution

  • 08800019600893 ()
LS-100

  • Intraoral optical scanning system
Real Arch is a dental 3D scanner intended to be used to digitally record topographical characteristics of teeth and surrounding tissues.The Real Arch is composed of a hand-piece, power hub, adapter and usb3.0 cable. The system produces 3D scans for use in computer- assisted design and manufacturing of dental restorations.
HDX WILL CORP.
Real Arch
In Commercial Distribution

  • 08800005200182 ()


  • Intraoral optical scanning system
Laser, Fluorescence Caries Detection
GOOD DOCTORS CO., LTD.
IC-WHCD100
In Commercial Distribution

  • 18800025400132 ()
  • 08800025400135 ()


  • Intraoral optical scanning system
No Description
DDS INC
COMFORT+
In Commercial Distribution

  • 08800160000030 ()


  • Intraoral optical scanning system
No Description
DDS INC
COMFORT+
In Commercial Distribution

  • 08800160000023 ()


  • Intraoral optical scanning system
No Description
DDS INC
COMFORT+
In Commercial Distribution

  • 08800160000016 ()


  • Intraoral optical scanning system
No Description
GNI Co.,Ltd
SS650
In Commercial Distribution

  • 08800046051484 ()


  • Intraoral optical scanning system
No Description
Ziyang Freqty Medical Equipment Co., Ltd.
PANDA free
In Commercial Distribution

  • 06975136230109 ()


  • Intraoral optical scanning system
No Description
Ziyang Freqty Medical Equipment Co., Ltd.
PANDA smart y
In Commercial Distribution

  • 06975136230062 ()


  • Intraoral optical scanning system
No Description
Ziyang Freqty Medical Equipment Co., Ltd.
PANDA smart p
In Commercial Distribution

  • 06975136230055 ()


  • Intraoral optical scanning system
No Description
Ziyang Freqty Medical Equipment Co., Ltd.
PANDA P3
In Commercial Distribution

  • 06975136230031 ()


  • Intraoral optical scanning system
No Description
Ziyang Freqty Medical Equipment Co., Ltd.
PANDA P2 Plus
In Commercial Distribution

  • 06975136230024 ()


  • Intraoral optical scanning system
No Description
Ziyang Freqty Medical Equipment Co., Ltd.
PANDA P2
In Commercial Distribution

  • 06975136230017 ()


  • Intraoral optical scanning system
No Description
Changzhou Sifary Medical Technology Co., Ltd.
Helios 600
In Commercial Distribution

  • 06975132957802 ()


  • Intraoral optical scanning system
The BreathID® Hp Lab System is intended for use to non-invasively measure changes in the 13CO2/ 12CO2 ratio of exhaled breath, which may be indicative of increased urease production associated with active Helicobacter pylori (H. pylori) infection in the stomach. The BreathID® Hp Lab System is indicated for use as an aid in the initial diagnosis and post treatment monitoring of H. pylori infection in adult patients and pediatric patients ages 3-17 years old. The BreathID® Hp Lab System consists of the appropriate IDkit: Hp™ kit, and the BreathID® Hp device, Auto Sampler and Lab Application
MERIDIAN BIOSCIENCE ISRAEL LTD
VS02000W
In Commercial Distribution

  • 07290016923391 ()

  • Height: 16 Inch
  • Width: 15 Inch
  • Depth: 22 Inch
  • Weight: 15 Kilogram


  • Infrared spectrometry breath analyser IVD
The BreathID® Hp Lab System is intended for use to non-invasively measure changes in the 13CO2/ 12CO2 ratio of exhaled breath, which may be indicative of increased urease production associated with active Helicobacter pylori (H. pylori) infection in the stomach. The BreathID® Hp Lab System is indicated for use as an aid in the initial diagnosis and post treatment monitoring of H. pylori infection in adult patients and pediatric patients ages 3-17 years old. The BreathID® Hp Lab System consists of the appropriate IDkit: Hp™ kit, and the BreathID® Hp device, Auto Sampler and Lab Application
MERIDIAN BIOSCIENCE ISRAEL LTD
VS02000
In Commercial Distribution

  • 07290016923384 ()

  • Height: 16 Inch
  • Width: 15 Inch
  • Depth: 22 Inch
  • Weight: 15 Kilogram


  • Infrared spectrometry breath analyser IVD
The BreathID® Smart System is intended for use to non-invasively measure changes in the 13CO2/12CO2 ratio of exhaled breath, which may be indicative of increased urease production associated with active Helicobacter pylori (H. pylori) infection in the stomach. The BreathID® Smart System is indicated for use as an aid in the initial diagnosis and post treatment monitoring H. pylori of infection in adult patients and pediatric patients ages 3-17 years old. The BreathID® Smart System consists of the appropriate IDkit: Hp™ kit and the BreathID® Smart device.
MERIDIAN BIOSCIENCE ISRAEL LTD
VS07000WR
Not in Commercial Distribution

  • 07290016923353 ()

  • Height: 16 Inch
  • Width: 15 Inch
  • Depth: 22 Inch
  • Weight: 15 Kilogram


  • Infrared spectrometry breath analyser IVD
The BreathID® Smart System is intended for use to non-invasively measure changes in the 13CO2/12CO2 ratio of exhaled breath, which may be indicative of increased urease production associated with active Helicobacter pylori (H. pylori) infection in the stomach. The BreathID® Smart System is indicated for use as an aid in the initial diagnosis and post treatment monitoring H. pylori of infection in adult patients and pediatric patients ages 3-17 years old. The BreathID® Smart System consists of the appropriate IDkit: Hp™ kit and the BreathID® Smart device.
MERIDIAN BIOSCIENCE ISRAEL LTD
VS07000W
In Commercial Distribution

  • 07290016923346 ()

  • Height: 16 Inch
  • Width: 15 Inch
  • Depth: 22 Inch
  • Weight: 15 Kilogram


  • Infrared spectrometry breath analyser IVD
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