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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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No Description
MetaSystems Hard & Software GmbH
Microscopic image acquisition
In Commercial Distribution

  • 04250406460007 ()


  • Laboratory instrument/analyser application software IVD
No Description
MetaSystems Hard & Software GmbH
Medical Device Data System
In Commercial Distribution

  • 04250406401000 ()


  • Clinical management support software IVD
No Description
MetaSystems Hard & Software GmbH
Karyotyping System
In Commercial Distribution

  • 04250406400003 ()


  • Karyotyping cell-image analyser IVD
SOFTWARE, CODE-STAT CASEVIEW SOFTWARE INSTALL
PHYSIO-CONTROL, INC.
21340
In Commercial Distribution

  • 00883873837788 ()
21340-000850

  • Medical equipment clinical data interfacing software
LICENCE CS MODEL+ V5 ALIGNER CAPABILITY
Dental Imaging Technologies Corporation
594483
In Commercial Distribution

  • 00693856000302 ()
594483

  • CAD/CAM software
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
The 3Shape Automate software is a web service for automatic design of crowns
3shape A/S
R1.2
In Commercial Distribution

  • 05902729753821 ()


  • Dental treatment application software
DentalSystem-backed web service for automatic designs of crowns.
3shape Trios A/S
R1.0
Not in Commercial Distribution

  • 05902729753654 ()


  • Dental treatment application software
Dental treatment application software
3shape A/S
R1.0
In Commercial Distribution

  • 05902729753555 ()


  • Dental treatment application software
Ortho System is a software system intended for use as a medical front-end for orthodontic clinics and laboratories. It supports orthodontic diagnosis, treatment planning and follow-up, CAD modelling of orthodontic appliances and indirect bonding as well as archiving of case information.
3shape A/S
85.x
In Commercial Distribution

  • 05902729753487 ()


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

  • 05902729752954 ()


  • Dental treatment application software
CAD/CAM software
3shape A/S
2018-1
Not in Commercial Distribution

  • 05902729752787 ()


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

  • 05902729752510 ()


  • CAD/CAM software
Orthodontic Software
Orchestrate 3d
1
In Commercial Distribution

  • 00860008123404 ()


  • Dental milling system, CAD/CAM, chairside
CEREC Ortho Software Version 2.1
SIRONA Dental Systems GmbH
6748359
In Commercial Distribution

  • E27667483590 ()


  • CAD/CAM software
CEREC Ortho Software Version 2.0.0
SIRONA Dental Systems GmbH
6697986
In Commercial Distribution

  • E27666979860 ()


  • CAD/CAM software
CEREC Ortho Software Version 1.2.0
SIRONA Dental Systems GmbH
6611169
Not in Commercial Distribution

  • E27666111690 ()


  • CAD/CAM software
CEREC Ortho Software Version 2.1 Upgrade
SIRONA Dental Systems GmbH
6784495
In Commercial Distribution

  • E27667844950 ()


  • CAD/CAM software
Orthodontic Software
PARK DENTAL RESEARCH CORP
O3D
In Commercial Distribution

  • D769O3D0 ()


  • CAD/CAM software
No Description
SWIFT HEALTH SYSTEMS INC.
Lower Patient Kit
In Commercial Distribution

  • 00850018135139 ()
8121

  • Orthodontic appliance/positioning tray kit
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