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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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Ikaros - 04250406400003

No Description
MetaSystems Hard & Software GmbH
Karyotyping System
In Commercial Distribution

  • 04250406400003 ()


  • Karyotyping cell-image analyser IVD

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

Inbrace Teeth Straightening System - 00850018135016

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

  • 00850018135016 ()
8111

  • Orthodontic appliance/positioning tray kit

Inbrace Teeth Straightening System - 00850018135009

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

  • 00850018135009 ()
8101

  • Orthodontic appliance/positioning tray kit

Inbrace Teeth Straightening System - 00850018135139

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

  • 00850018135139 ()
8121

  • Orthodontic appliance/positioning tray kit

Orchestrate 3D - 00860008123404

Orthodontic Software
Orchestrate 3d
1
In Commercial Distribution

  • 00860008123404 ()


  • Dental milling system, CAD/CAM, chairside

3Shape Ortho System - 05902768365283

3Shape’s Ortho System™ is a software system used for the management of 3D scanned orthodontic models of the patients, orthodontic diagnosis by measuring, analyzing, inspecting and visualize 3D scanned orthodontic models, virtual planning of orthodontic treatments by simulating tooth movements, virtual placement of orthodontic brackets on the 3D models and design of orthodontic appliances based on 3D scanned orthodontic models, including transfer methods for indirect bonding of brackets. Output includes only Export Model (also called dental casts), Custom Metal Bands (also called metal bands), and Indirect Bonding Transfer Trays (also called orthodontic bracket placement trays). All devices are to be fabricated from FDA cleared materials.
3shape A/S
2015-1
Not in Commercial Distribution

  • 05902768365283 ()


  • CAD/CAM software
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