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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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Splint Design - 05902729752954

Dental treatment application software
3shape A/S
1.1.x
Not in Commercial Distribution

  • 05902729752954 ()


  • Dental treatment application software

Ortho System - 05902729752787

CAD/CAM software
3shape A/S
2018-1
Not in Commercial Distribution

  • 05902729752787 ()


  • CAD/CAM software

Ortho System - 05902729752510

CAD/CAM software
3shape A/S
2017-1
Not in Commercial Distribution

  • 05902729752510 ()


  • CAD/CAM software

CS MODEL+ - 00693856000302

LICENCE CS MODEL+ V5 ALIGNER CAPABILITY
Dental Imaging Technologies Corporation
594483
In Commercial Distribution

  • 00693856000302 ()
594483

  • CAD/CAM software

Orchestrate 3D - 00860008123404

Orthodontic Software
Orchestrate 3d
1
In Commercial Distribution

  • 00860008123404 ()


  • Dental milling system, CAD/CAM, chairside

Inbrace Teeth Straightening System - 00850018135139

No Description
SWIFT HEALTH SYSTEMS INC.
Lower Patient Kit
In Commercial Distribution

  • 00850018135139 ()
8121

  • Orthodontic appliance/positioning tray kit

Inbrace Teeth Straightening System - 00850018135122

No Description
SWIFT HEALTH SYSTEMS INC.
Digital Engancement
In Commercial Distribution

  • 00850018135122 ()
8131

  • Orthodontic appliance/positioning tray kit

InBrace Teeth Straightening System (Gen 2.0) - 00850018135054

No Description
SWIFT HEALTH SYSTEMS INC.
Lower Fitting Kit
In Commercial Distribution

  • 00850018135054 ()
85003

  • Orthodontic appliance/positioning tray kit

InBrace Teeth Straightening System (Gen 2.0) - 00850018135047

No Description
SWIFT HEALTH SYSTEMS INC.
Fitting Kit
In Commercial Distribution

  • 00850018135047 ()
85000

  • Orthodontic appliance/positioning tray kit

InBrace Teeth Straightening System (Gen 2.0) - 00850018135030

No Description
SWIFT HEALTH SYSTEMS INC.
Upper Fitting Kit
In Commercial Distribution

  • 00850018135030 ()
85002

  • Orthodontic appliance/positioning tray kit
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