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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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
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
Laser, Fluorescence Caries Detection
GOOD DOCTORS CO., LTD.
IC-WHCD100
In Commercial Distribution

  • 18800025400132 ()
  • 08800025400135 ()


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

  • 08800046051484 ()


  • Intraoral optical scanning system
The POC-ASI10 Auto sampler expands the number of breath collection bags that can be set up and analyzed by the POCone Infrared Spectrophotometer.
OTSUKA ELECTRONICS CO.,LTD.
POC-AS10
In Commercial Distribution

  • 04987035388517 ()


  • Infrared spectrometry breath analyser IVD
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
Arj Medical, Inc.
PPUBTA-16
In Commercial Distribution

  • 00860001810370 ()


  • Infrared spectrometry breath analyser IVD
No Description
Arj Medical, Inc.
PPUBTA-02
In Commercial Distribution

  • 00860001810363 ()


  • Infrared spectrometry breath analyser IVD
No Description
Arj Medical, Inc.
PPUBTLA-04
In Commercial Distribution

  • 00860001810387 ()


  • Infrared spectrometry breath analyser IVD
Intraoral Optical Scanner
Ori Inc
Ori 2 Scanner
In Commercial Distribution

  • 00860008859532 ()
10009

  • Intraoral optical scanning system
Intraoral Optical Scanning Tip
Ori Inc
Ori 2 Tip
In Commercial Distribution

  • 00860008859525 ()
10008

  • Intraoral optical scanning system
Intraoral Optical Scanning System
Ori Inc
Ori 2
In Commercial Distribution

  • 00860008859518 ()
10007

  • Intraoral optical scanning system
Intraoral Optical Scanning System
Ori Inc
Ori One
In Commercial Distribution

  • 00860008859501 ()
10000

  • Intraoral optical scanning system
IS 3800
Dental Imaging Technologies Corporation
5943725
In Commercial Distribution

  • 00693856000043 ()
5943725

  • Intraoral optical scanning system
No Description
Dental Imaging Technologies Corporation
5943063
In Commercial Distribution

  • 00693856000036 ()
5943063

  • Intraoral optical scanning system
No Description
Dental Imaging Technologies Corporation
5941307
In Commercial Distribution

  • 00693856000012 ()
5941307

  • Intraoral optical scanning system
No Description
Dental Imaging Technologies Corporation
6568745
In Commercial Distribution

  • 00693856000005 ()
6568745

  • Intraoral optical scanning system
No Description
3shape Trios A/S
TSL-01
In Commercial Distribution

  • 05902729753777 ()


  • Intraoral optical scanning system
No Description
3shape Trios A/S
LP1-2
In Commercial Distribution

  • 05902729753685 ()


  • Intraoral optical scanning system
No Description
3shape Trios A/S
TB-04
In Commercial Distribution

  • 05902729753746 ()
  • 05902729753661 ()


  • Intraoral optical scanning system
Intraoral scanner w. protection tip
3shape Trios A/S
S3-2
Not in Commercial Distribution

  • 05902729753616 ()


  • Intraoral optical scanning system
Cord
3shape Trios A/S
TSC-01
Not in Commercial Distribution

  • 05902729753593 ()


  • Intraoral optical scanning system
Pod for pen-grip configuration
3shape Trios A/S
PS3-2
Not in Commercial Distribution

  • 05902729753586 ()


  • Intraoral optical scanning system
Intraoral optical scanning system, pod with wireless pen grip scanner
3shape Trios A/S
S3P-2
Not in Commercial Distribution

  • 05902729753579 ()


  • Intraoral optical scanning system
Monitoring of changes in the dentition over time by comparison of TRIOS 3D images
3shape Trios A/S
R1.5
In Commercial Distribution

  • 05902729753524 ()


  • Intraoral optical scanning system
Intraoral optical scanning system, MOVE+ cart with pen grip scanner
3shape Trios A/S
S3A-18
In Commercial Distribution

  • 05902729753012 ()


  • Intraoral optical scanning system
Calibration kit
3shape Trios A/S
TST-02
In Commercial Distribution

  • 05902729752909 ()


  • Intraoral optical scanning system
Cord
3shape Trios A/S
TSC-01
In Commercial Distribution

  • 05902729752893 ()


  • Intraoral optical scanning system
Protection tip
3shape Trios A/S
TST-03
In Commercial Distribution

  • 05902729752886 ()


  • Intraoral optical scanning system
Scanner tip
3shape Trios A/S
TST-01
In Commercial Distribution

  • 05902729752930 ()
  • 05902729752879 ()


  • Intraoral optical scanning system
Pod for pen-grip configuration wireless
3shape Trios A/S
PS3-4
In Commercial Distribution

  • 05902729752862 ()


  • Intraoral optical scanning system
Pod for pen-grip configuration
3shape Trios A/S
PS3-2
In Commercial Distribution

  • 05902729752855 ()


  • Intraoral optical scanning system
Intraoral scanner w. protection tip
3shape Trios A/S
S3-2
In Commercial Distribution

  • 05902729752848 ()


  • Intraoral optical scanning system
Intraoral optical scanning system, MOVE cart with wireless pen grip scanner
3shape Trios A/S
S3A-14
Not in Commercial Distribution

  • 05902729752831 ()


  • Intraoral optical scanning system
Intraoral optical scanning system, MOVE cart with pen grip scanner
3shape Trios A/S
S3A-10
Not in Commercial Distribution

  • 05902729752824 ()


  • Intraoral optical scanning system
Monitoring of changes in the dentition over time by comparison of TRIOS 3D images
3shape Trios A/S
2017-1
Not in Commercial Distribution

  • 05902729752602 ()


  • Intraoral optical scanning system
The TRIOS Patient Monitoring software can be used for the visualization and comparison of 3D scans of the dentition.
3shape Trios A/S
R2.3
In Commercial Distribution

  • 05902729754057 ()


  • Intraoral optical scanning system
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