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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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IPS CaseDesigner 1.2 for Windows 64-bit
Nobel Biocare AB
1.2
Not in Commercial Distribution

  • 07332747124996 ()
300011

  • Dental treatment application software
DTX Studio Implant 3.3 for Mac
Nobel Biocare AB
3.3
Not in Commercial Distribution

  • 07332747158809 ()
300843

  • Dental treatment application software
DTX Studio Implant 3.3 for Win 64-bit
Nobel Biocare AB
3.3
Not in Commercial Distribution

  • 07332747158793 ()
300843

  • Dental treatment application software
IPS CaseDesigner 1.4 Mac
Nobel Biocare AB
1.4
In Commercial Distribution

  • 07332747157673 ()
300011

  • Dental treatment application software
IPS CaseDesigner 1.4 for Windows 64-bit
Nobel Biocare AB
1.4
In Commercial Distribution

  • 07332747157666 ()
300011

  • Dental treatment application software
Rapid System Update
Ischemaview, Inc.
6.1.0
In Commercial Distribution

  • B761R610 ()


  • Radiological PACS software
Rapid Platform plus cleared indications for Rapid version 6.x
Ischemaview, Inc.
6.x
In Commercial Distribution

  • B761R60 ()


  • Radiological PACS software
The Progressive Orthodontics App is an orthodontic appliance design and treatment simulation software. This software is for use by dental professionals in a healthcare facility to assist in diagnosis and design solutions for patients. Digital scans (3D) of a patient’s dentition can be loaded into the software and the dental professional can then review different treatment plans and simulations for each individual patient and decide on the most appropriate treatment.
PROGRESSIVE AMERICA, INC.
2.0
In Commercial Distribution

  • D16420251 ()


  • CAD/CAM software
The Progressive Orthodontics App is an orthodontic appliance design and treatment simulation software. This software is for use by dental professionals in a healthcare facility to assist in diagnosis and design solutions for patients. Digital scans (3D) of a patient’s dentition can be loaded into the software and the dental professional can then review different treatment plans and simulations for each individual patient and decide on the most appropriate treatment.
PROGRESSIVE AMERICA, INC.
0.9.6
In Commercial Distribution

  • D16409625 ()


  • CAD/CAM software
customized SOLOASSIST II for Dexter, incl. Power supply and supply cable
Aktormed GmbH
212499
In Commercial Distribution

  • 04260463844993 ()
212499

  • Surgical camera holder
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