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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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Bien-Air Surgery SA
1700074
In Commercial Distribution

  • J00717000740011 ()
1700074-001

  • Surgical power tool system control unit, line-powered
integrable devices are electronic boards that allow the control of Bien-Air Electric micromotors as well as various dental instruments. They are intended to be integrated into a dental unit (kart or dental chair). iOPTIMA INT and Integrated Dental Unit Platform (IDUP) are dental chair’s integrated device allowing the control of dental and surgical micromotors parameters (such as torque, speed, and direction of rotation), irrigation pump and dental accessories via a user interface. For iOptima INT devices, the user interface is and Apple Device.
Bien-Air Dental SA
1601196-005
In Commercial Distribution

  • J00716011960051 ()


  • Surgical power tool system control unit, line-powered
Chiropro are electrical medical devices used to run dental instruments
Bien-Air Dental SA
1601147-001E
In Commercial Distribution

  • J0071601147001E1 ()


  • Surgical power tool system control unit, line-powered
Chiropro are electrical medical devices used to run dental instruments
Bien-Air Dental SA
1601147-001
In Commercial Distribution

  • J00716011470011 ()
1601147-001

  • Surgical power tool system control unit, line-powered
Chiropro are electrical medical devices used to run dental instruments
Bien-Air Dental SA
1601102-001
In Commercial Distribution

  • J00716011020011 ()
1601102-001

  • Surgical power tool system control unit, line-powered
Chiropro are electrical medical devices used to run dental instruments
Bien-Air Dental SA
1601101-001
In Commercial Distribution

  • J00716011010011 ()
1601101-001

  • Surgical power tool system control unit, line-powered
MEG-ENGINE II is an electrical medical device used to run dental instruments
Bien-Air Dental SA
1601100-001
In Commercial Distribution

  • J00716011000011 ()
1601100-001

  • Surgical power tool system control unit, line-powered
iOptima consoles are control units designed to drive Bien-Air Dental SA's dental micromotors, and to control torque, speed, and direction of rotation via an Apple iDevice (iPod or iPad).
Bien-Air Dental SA
1601076-001
In Commercial Distribution

  • J00716010760011 ()
1601076-001

  • Surgical power tool system control unit, line-powered
iOptima consoles are control units designed to drive Bien-Air Dental SA's dental micromotors, and to control torque, speed, and direction of rotation via an Apple iDevice (iPod or iPad).
Bien-Air Dental SA
1601075-001
In Commercial Distribution

  • J00716010750011 ()
1601075-001

  • Surgical power tool system control unit, line-powered
iOptima consoles are control units designed to drive Bien-Air Dental SA's dental micromotors, and to control torque, speed, and direction of rotation via an Apple iDevice (iPod or iPad).
Bien-Air Dental SA
1601074-001
In Commercial Distribution

  • J00716010740011 ()
1601074-001

  • Surgical power tool system control unit, line-powered
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