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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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
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
VS07000R
Not in Commercial Distribution

  • 07290016923278 ()

  • 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
VS07000
In Commercial Distribution

  • 07290016923223 ()

  • 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
VS01082R
Not in Commercial Distribution

  • 07290016923162 ()

  • Height: 16 Inch
  • Width: 15 Inch
  • Depth: 22 Inch
  • Weight: 15 Kilogram
  • Height: 10 Inch
  • Width: 15.7 Inch
  • Depth: 18 Inch
  • Weight: 9 Kilogram


  • Infrared spectrometry breath analyser IVD
The BreathID® Hp System is intended for use to continually and non-invasively measure changes in the13CO2 /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 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 System consists of the appropriate IDkit:Hp™ kit and the BreathID® Hp test device.
MERIDIAN BIOSCIENCE ISRAEL LTD
VS01000R
Not in Commercial Distribution

  • 07290016923148 ()

  • Height: 16 Inch
  • Width: 15 Inch
  • Depth: 22 Inch
  • Weight: 15 Kilogram
VS01000R

  • 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
VS01082
In Commercial Distribution

  • 07290016923070 ()

  • Height: 16 Inch
  • Width: 15 Inch
  • Depth: 22 Inch
  • Weight: 15 Kilogram
  • Height: 10 Inch
  • Width: 15.7 Inch
  • Depth: 18 Inch
  • Weight: 9 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
VS01085
In Commercial Distribution

  • 07290016923063 ()

  • Height: 10 Inch
  • Width: 15.7 Inch
  • Depth: 18 Inch
  • Weight: 9 Kilogram


  • Infrared spectrometry breath analyser IVD
The BreathID® Hp System is intended for use to continually and non-invasively measure changes in the13CO2 /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 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 System consists of the appropriate IDkit:Hp™ kit and the BreathID® Hp test device.
MERIDIAN BIOSCIENCE ISRAEL LTD
VS01000
In Commercial Distribution

  • 07290016923056 ()

  • Height: 16 Inch
  • Width: 15 Inch
  • Depth: 22 Inch
  • Weight: 15 Kilogram
VS01000

  • Infrared spectrometry breath analyser IVD
No Description
Fussen Technology Co., Ltd.
S6500
In Commercial Distribution

  • 06974566270051 ()


  • Intraoral optical scanning system
No Description
Fussen Technology Co., Ltd.
S7000 Premium
In Commercial Distribution

  • 06974566270037 ()


  • Intraoral optical scanning system
No Description
Fussen Technology Co., Ltd.
S7000
In Commercial Distribution

  • 06974566270020 ()


  • Intraoral optical scanning system
No Description
Fussen Technology Co., Ltd.
S6000
In Commercial Distribution

  • 06974566270006 ()


  • Intraoral optical scanning system
The intraoral scanner uses an optical scanning method to directly collect 3D geometric data of the teeth and gums to be repaired in the patient's mouth, and provides 3D digital models for CAD/CAM denture design and processing.
Shining 3D Tech Co., Ltd.
Elegant 3
In Commercial Distribution

  • 06970163081779 ()


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

  • 18800160000006 ()


  • Intraoral optical scanning system
The intraoral scanner uses an optical scanning method to directly collect 3D geometric data of the teeth and gums to be repaired in the patient's mouth, and provides 3D digital models for CAD/CAM denture design and processing.
Shining 3D Tech Co., Ltd.
Aoralscan 2
In Commercial Distribution

  • 06970163080024 ()


  • Intraoral optical scanning system
The intraoral scanner uses an optical scanning method to directly collect 3D geometric data of the teeth and gums to be repaired in the patient's mouth, and provides 3D digital models for CAD/CAM denture design and processing.
Shining 3D Tech Co., Ltd.
Aoralscan 2
In Commercial Distribution

  • 06970163080017 ()


  • Intraoral optical scanning system
No Description
Wuhan Ruler Technology Co., Ltd.
JMO1
In Commercial Distribution

  • 16976986101011 ()


  • Intraoral optical scanning system
No Description
Changzhou Sifary Medical Technology Co., Ltd.
Helios 500
In Commercial Distribution

  • 06941877807962 ()


  • Intraoral optical scanning system
VivaScan Intraoral Scanner
IVOCLAR VIVADENT AKTIENGESELLSCHAFT
740278
In Commercial Distribution

  • DIVO7402780 ()
  • DIVO7402781 ()
740278

  • Intraoral optical scanning system
No Description
Alliedstar Medical Equipment Co., Ltd.
ST 200E Handpiece
In Commercial Distribution

  • 06973993440204 ()


  • Intraoral optical scanning system
No Description
Alliedstar Medical Equipment Co., Ltd.
NeoScan 2000-Handpiece
In Commercial Distribution

  • 06973993440099 ()
91041

  • Intraoral optical scanning system
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